# K081553: Aed Bipolar Forceps, Model 13-1646

- Pathway: 510(k) (Traditional)
- Applicant: National Advanced Endoscopy Devices, Inc.
- Decided: Sep 29, 2008 after 118 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 K945975 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023813: Bipolar Forceps, Richard Wolf Medical Instruments Corp. (2003) Summary page 1.
- K935237: Stryker Endoscopic Instruments and Accessories, Stryker Endoscopy (1994) Summary page 1.

## Indications for use
AED Bipolar Forceps are reusable devices (bipolar forceps/scissors and electrodes) that facilitate grasping, cutting and manipulation of soft tissue during laparoscopic procedures with the use of high frequency electrical current (bipolar electrocautery). AED Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal ligation/coagulation for sterilization procedures. Do not use these bipolar forceps for these procedures.

Source page: https://510kreport.com/device/K081553
Methodology: https://510kreport.com/methodology