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Vanguard Reprocessed Electric Biopsy Forceps

by Vanguard Medical Concepts, Inc.

510(k) K011800

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011800 Date27 Sep 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
NLU
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Vanguard Reprocessed Electric Biopsy Forceps are reprocessed versions of OEM devices, consisting of a flexible, electrically isolated sheath with distal grasping cups controlled by a proximal handle. These forceps are designed for biopsy procedures and are intended for use with a compatible electrosurgical unit, endoscope, and patient grounding pad. The device is classified as a Class II medical device under product code NLU.

The Vanguard Reprocessed Electric Biopsy Forceps are supplied as reprocessed devices and are intended for single-use applications. The device received FDA 510(k) clearance on September 27, 2001, with K number K011800, and was determined to be substantially equivalent. The device is manufactured by Vanguard Medical Concepts, Inc. in Lakeland, Florida, and is authorized for use in gastroenterology and urology procedures.

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Questions

AI-generated answers, 24 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 are the Vanguard Reprocessed Electric Biopsy Forceps used for?

    These forceps are designed for biopsy procedures in gastroenterology and urology, intended for use with compatible electrosurgical units, endoscopes, and patient grounding pads.

  • Are the Vanguard Reprocessed Electric Biopsy Forceps single-use or reusable?

    The forceps are supplied as reprocessed devices and are intended for single-use applications only, ensuring safety and preventing cross-contamination between patients.

  • What is the regulatory status of the Vanguard Reprocessed Electric Biopsy Forceps?

    The device received FDA 510(k) clearance on September 27, 2001, with K number K011800, and was determined to be substantially equivalent to predicate devices.

  • Who manufactures the Vanguard Reprocessed Electric Biopsy Forceps?

    The device is manufactured by Vanguard Medical Concepts, Inc. located in Lakeland, Florida, and is authorized for use in specific medical procedures.