# K012986: Bipolar Irrigation Forceps

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Oct 3, 2001 after 27 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: 1 generation back to K944955 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971310: Aesculap Jet Irrigation System, Aesculap, Inc. (1997) Summary page 1.
- K944955: Aesculap Thoracoscopic Instruments, Aesculap, Inc. (1994) Summary page 1.
- (no number) pre-amendment devices: named in the summary without a submission number

## Indications for use
Aesculap's Bipolar Irrigation Forceps are designed to be used with Aesculap’s current Jet Irrigation System (#K971310) and Bipolar Coagulator (#K952524). The Bipolar Irrigation Forceps are intended for use in electrosurgery for coagulation and irrigation of selected tissue.

Source page: https://510kreport.com/device/K012986
Methodology: https://510kreport.com/methodology