# K110695: Bipolar HF Device

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jun 28, 2011 after 106 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: 4 generations back to K932293 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952524: Aesculap Biopolar Coagulator, Aesculap, Inc. (1995) Summary page 1.
- K945914: Bipolar Generator Model 2352, Richard Wolf Medical Instruments Corp. (1995) Summary page 1.
- K953195: Valleylab Force 300, Valleylab, Inc. (1995) Summary page 1.
- K102913: Forcetriad, Covidien, Formerly Valleylab, A Division of Tyco H (2011). Cleared while this submission was under review Summary page 1.

## Indications for use
Aesculap's Bipolar Coagulator (GN16O) is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.

Source page: https://510kreport.com/device/K110695
Methodology: https://510kreport.com/methodology