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Surgi-Link Endoscopic Bipolar Forceps

by Unimed Surgical Products, Inc.

510(k) K944045

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 NumberK944045 Date8 Sep 1994ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

The Surgi-Link Endoscopic Bipolar Forceps is a device used in endoscopic procedures for grasping and coagulating tissue. It is designed for use in general and plastic surgery applications.

This device received FDA 510(k) clearance under K944045 and is substantially equivalent to a predicate device. It is supplied by Unimed Surgical Products, Inc. and is intended for use in clinical settings as a reusable endoscopic instrument.

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Questions

AI-generated answers, 21 Sep 2026

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

  • What is the Surgi-Link Endoscopic Bipolar Forceps used for?

    The Surgi-Link Endoscopic Bipolar Forceps is used in endoscopic procedures for grasping and coagulating tissue, specifically designed for general and plastic surgery applications as stated in the device description.

  • Is the Surgi-Link Endoscopic Bipolar Forceps reusable or single-use?

    The device is intended for use as a reusable endoscopic instrument, as explicitly indicated in the description which states it is 'intended for use in clinical settings as a reusable endoscopic instrument'.

  • Who manufactures the Surgi-Link Endoscopic Bipolar Forceps and where are they located?

    The Surgi-Link Endoscopic Bipolar Forceps is manufactured by Unimed Surgical Products, Inc., located at 10401 Belcher Rd., Largo, FL 34647, United States, based on the manufacturer and address details provided in the device data.