# K230432: Single Use Bipolar Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Hg Innovations, Ltd.
- Decided: May 18, 2023 after 90 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: 2 generations back to K974593 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213386: Titan Manufacturing Bipolar Forceps, Titan Manufacturing, Inc. (2021) Summary page 4.

## Indications for use
Single-use, bipolar forceps are intended for bipolar coagulation to remove tissue and control bleeding by use of high frequency electrical current. The bipolar forceps must be operated with the following parameters: -Frequency range between 300 kHz-1,000 kHZ; -Maximum generator operating voltage 600Vp.

Source page: https://510kreport.com/device/K230432
Methodology: https://510kreport.com/methodology