# K083162: Stingray Electrosurgical Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Stingray Surgical Products, Inc.
- Decided: Jan 12, 2009 after 77 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K923332 (1992). 7 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070997: Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables, Model 5015-XX, Pro-Med Instruments GmbH (2007) Summary page 1.

## Most influential descendants
- K093108: Stryker Bipolar Forceps (2010), 10 descendants of its own
- K152219: PK AIM (2015), 3 descendants of its own
- K110143: Het Bipolar Electrocautery Forceps (2011), 3 descendants of its own
- K161825: PK AIM (2016), 2 descendants of its own
- K121085: Het Bipolar Ligator System (2012), 2 descendants of its own

## Recalls of this device
- May 23, 2012 · Class II · Z-2011-2012: On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to "Instructions For Use" of Bipolar Forceps not being cleared by FDA and incorrect "Instructions For U

## Indications for use
Designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. Coagulation is achieved using electrosurgical energy generated by the electro surgical generator unit and activated by a footswitch. The Stingray Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Source page: https://510kreport.com/device/K083162
Methodology: https://510kreport.com/methodology