# K971677: Accu-Surg BI-Polar Electrodes, L-Hook, Needle, Ball, Bipolar Cord

- Pathway: 510(k) (Traditional)
- Applicant: Transamerican Technologies Intl.
- Decided: Aug 20, 1997 after 105 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ACCU-Surg Bipolar Laparoscopic Electrodes are intended to be used with the ACCU-Surg Suction / Irrigation Cannula. They are surgical tools for cutting and coagulation used for GYN and General Surgery for such procedures as coagulation of endometrium, laparoscopic myomectomy, laparoscopic leiomyoma coagulation (myolysis), bleeding control of pelvic vessels and laparoscopic cholecystectomy. Pathology and/or surgeons choice will determine the tip style used.

Source page: https://510kreport.com/device/K971677
Methodology: https://510kreport.com/methodology