# K951035: Bipolar Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Megadyne Medical Products, Inc.
- Decided: Apr 7, 1995 after 32 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Richard Wolf: named in the summary without a submission number
- (no number) Karl Storz: named in the summary without a submission number
- (no number) Apple Medical: named in the summary without a submission number
- (no number) Linvatec: named in the summary without a submission number
- (no number) MegaDyne Medical: named in the summary without a submission number

## Indications for use
This device is used in cases where bipolar electrosurgery is employed.

Source page: https://510kreport.com/device/K951035
Methodology: https://510kreport.com/methodology