# K964176: Tecno Reusable, Electrosurgical, Bipolar Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Tecno Instruments (Usa), Inc.
- Decided: Aug 14, 1997 after 300 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 intended use of the Tecno reusable bipolar electrosurgical forceps is to grasp and coagulate (control bleeding) by use of high-frequency electrical current. The forceps can be used multiple times and have been AAMI performance tested after 20 exposures to steam sterilization. The areas of specialty that the Tecno electrosurgical bipolar forceps will be used is: neurosurgical, opthalmic, plastic and reconstructive surgical procedures. Indications for use are hemorrhaging of compromised tissue and subsequent need to coagulate during invasive surgical procedures.

Source page: https://510kreport.com/device/K964176
Methodology: https://510kreport.com/methodology