Sandel Weighted Safety Scalpel

Model: Product Codes: 2210-N, 2211-N, 2215-N, 2220-N, 2210-L, 2211-L, 2215-L, Affected:

510 K exempt Device Listing Number D129456 Model Number 2210-N LN 0563 Jan 2016 LN 2263 Jul 2016

General and Plastic Surgery Devices

1

No

Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.

Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade || Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA || Emergo Europe Molenstraat 15 2513 BH The Hague || The Netherlands || Made in China || Packaged in Mexico || Ansell || A manual surgical scalpel blade for making incisions in various general surgical procedures.

510 K exempt Device Listing Number D129456 Model Number 2211-N LN 2782 9/2015 LN 1413 4/2016 LN 1623 5/2016

General and Plastic Surgery Devices

1

No

Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.

Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade || Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA || Emergo Europe Molenstraat 15 2513 BH The Hague || The Netherlands || Made in China || Packaged in Mexico || Ansell || A manual surgical scalpel blade for making incisions in various general surgical procedures.

510 K exempt Device Listing Number D129456 Model Number 2210-L  1) LN 0662 2/2015 2) LN 2052 6/2015

General and Plastic Surgery Devices

1

No

Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.

Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade || Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA || Emergo Europe Molenstraat 15 2513 BH The Hague || The Netherlands || Made in China || Packaged in Mexico || Ansell || A manual surgical scalpel blade for making incisions in various general surgical procedures.

510 K exempt Device Listing Number D129456 Model Number 2211-L LN 2962

General and Plastic Surgery Devices

1

No

Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.

Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade || Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA || Emergo Europe Molenstraat 15 2513 BH The Hague || The Netherlands || Made in China || Packaged in Mexico || Ansell || A manual surgical scalpel blade for making incisions in various general surgical procedures.