# K093108: Stryker Bipolar Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Jun 22, 2010 after 264 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K923332 (1992). 9 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083162: Stingray Electrosurgical Forceps, Stingray Surgical Products, Inc. (2009) Summary page 2.
- K960009: Storz S2050 Series Bipolar Forceps, Storz Instrument Co. (1996) Summary page 2.
- K992931: Non-Stick Bipolar Forceps, Silverglide Surgical Technologies (1999) Summary page 2.

## Most influential descendants
- 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
- K163373: PK AIM (2016), 1 descendant of its own

## Indications for use
The Stryker Bipolar Forceps are intended to be used during bipolar electrosurgery to grasp, manipulate and coagulate selected soft tissue. They are connected through a suitable bipolar cable to the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. The Stryker Bipolar Forceps have not been shown to be effective for tubal ligation or tubal cauterization for sterilization procedures and should not be used for these procedures.

Source page: https://510kreport.com/device/K093108
Methodology: https://510kreport.com/methodology