15 x 100mm Kii Optical Access System, non- threaded

Alert removal device - applied medical

Lot Number / Expiration Date:1001381/2008-08 UPC Codes:C8004 +H699C80040K

General and Plastic Surgery Devices

2

No

Nationwide

The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath. Impervious Sleeve, Skin Marker. Sterile Lubricant, and Incision Template.

Model: Models: APP-C4130, APP-C4130-S, Affected: Lot Numbers: 1145945, 1147900, 1148677, 1154637, 1159491, 1162504, 1168638, 1171631

Model: Model: CD004, Affected: 75 lots

Model: CA090, Affected: All lots and batches

LOT NUMBER(S): 1121903

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's AM CHOLE KIT-TAM1; Model Number: K0509 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1118775, 1118776, 1118777, 1119556, 1119558,1119559, 1119565, 1119566, 1119567

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's Direct Drive Laparoscopic Clip Applier; Model Number: CA090 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures

LOT NUMBER(S): 1120791

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's GELPOINT LAP CHOLE KIT 2; Model Number: CK102 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

Model Number CD004. Lot Nubmers: 1161268, 1161269, 1164934, 1168358, 1168361, 1169317, 1169318, 1170694, 1170700, 1170701, 1171214, 1172482, 1172664, 1174287, 1174793, 1174857, 1175123, 1175280, 1175472, 1176555, 1177023, 1177871, 1179069, 1179392, 1179460, 1179775, 1179890, 1180291, 1180411, 1180576, 1181647, 1181648, 1181649, 1181939, 1182760, 1182934, 1183225, 1183823, 1183957, 1184273, 1184728, 1184915, 1184916, 1187779, 1188817, 1189117, 1189957, 1190294, 1190358, 1191208, 1192057, 1192969, 1193196, 1193661, 1194010, 1194666, 1194807, 1195518, 1195727, 1195997, 1197182, 1197404, 1197832, 1198055, 1198968, 1199899, 1200658, 1200828, 1200829, 1200830, 1201739, 1201740, 1201741, 1203154, 1204054.

General and Plastic Surgery Devices

2

No

Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, New Zealand, Netherlands, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

Applied Medical's Inzii¿ 12/15mm Retrieval System. || Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

LOT NUMBER(S): 1121545, 1121972, 1121973, 1121962, 1122267

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's KW/MOH LAP CHOLE KIT; Model Number: K2184 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1121989

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1121811

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT - 1A; Model Number: K0522 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1122206

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT 5 GK; Model Number: GK105 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1121985

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT 7 GK; Model Number: GK107 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1121907

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT 8 GK; Model Number: GK108 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1121687

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT 9 GK; Model Number: GK109-H || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1121587

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT - BLADED; Model Number: K0552 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1121822

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT ; Model Number: K0491 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1121504, 1122116

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT ; Model Number: K0492 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1122117

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT ; Model Number: K0630 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1122194

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT ; Model Number: K0684 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.

LOT NUMBER(S): 1121706

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VT, WA, and WI and the countries of Australia, Europe, Japan, and Kuwait.

Applied Medical's LAP CHOLE KIT ; Model Number: K2114 || The device is used to close a clip in order to ligate a tubular structure or vessel in laparoscopic and general surgical procedures.