# K973295: Biopolar Button Electrode, WL 150MM, W/Suction Applicator/WL 280MM, W/Suction Applicator (8801.451

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Nov 26, 1997 after 85 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 K945805 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945805: Wells Johnson Weco Monopolar/Frazier Suction Probe, Wells Johnson Co. (1994) Summary page 1.

## Indications for use
Richard Wolf Bipolar Button Electrode with Suction Applicator is designed for use in plastic and reconstructive surgery. The device provides a method of coagulating small blood vessels that bleed as a result of blunt dissection of tissue subcutaneously. When used in conjunction with the suction applicator, smoke caused by the cauterization of tissue is evacuated from the operative site.

Source page: https://510kreport.com/device/K973295
Methodology: https://510kreport.com/methodology