# K091259: Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Jan 15, 2010 after 261 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: 3 generations back to K932293 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051950: Inscope Multi-Clip Applier, Models IN22321, IN23321, Ethicon Endo-Surgery, Inc. (2005)
- K033421: Erbe Biclamp Open and Laparoscopic Instruments, Erbe USA, Inc. (2004)
- K062517: Electrosurgical Hemostatic Forceps Series, Olympus Medical Systems Corporation (2006) Summary page 1.
- K973384: Ethicon Non-Stick Bipolar Forceps, ETHICON, Inc. (1997) Summary page 1.

## Indications for use
The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are intended for use in endoscopic procedures where fusion of vessels or tissue bundles is performed. The device can be used on vessels up to 3 mm and bundles as large as will fit in the jaws of the instrument. The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. It is not recommended for use with other manufacturer's generators.

Source page: https://510kreport.com/device/K091259
Methodology: https://510kreport.com/methodology