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Bipolar Coagulator/Irriagation System

by Valley Forge Scientific Corp.

510(k) K923928

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923928 Date22 Jan 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Bipolar Coagulator/Irrigation System, classified under Electrosurgical, Cutting & Coagulation & Accessories (Product Code: GEI). It combines bipolar electrosurgical coagulation with irrigation capabilities to control bleeding and maintain a clear surgical field during procedures, particularly in plastic surgery applications.

The system is intended for use in surgical settings and is single-use as per its FDA 510(k) clearance (K923928). It adheres to 21 CFR 878.4400 and is regulated under Class II – Special Controls. No specific MRI safety or sterility details are provided beyond standard surgical device requirements, and it is supplied as a complete, ready-to-use unit.

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