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Gibbons Sterile Trocar Kits

by Gibbons Surgical Corp.

510(k) K012198

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 · Special NumberK012198 Date9 Aug 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  • Withdrawn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
FBQ
Device Class
Class II
Regulation
21 CFR Part 876.5090
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

Gibbons Sterile Trocar Kits are devices intended for use during laparoscopic or endoscopic surgery under the guidance of a physician. They are classified as trocars in the gastro-urology specialty and are designed to facilitate access to body cavities during surgical procedures.

The kits are supplied sterile and are intended for single-use. They are used in clinical or surgical settings by physicians and have received FDA 510(k) clearance under K012198, with a determination of substantial equivalence. The device is regulated as a Class II medical device under regulation number 876.5090.

Other devices from Gibbons Surgical Corp.

Questions

AI-generated answers, 27 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 Gibbons Sterile Trocar Kit used for?

    The Gibbons Sterile Trocar Kit is intended for use during laparoscopic or endoscopic surgery under physician guidance to facilitate access to body cavities, specifically classified for gastro-urology procedures.

  • Is the Gibbons Sterile Trocar Kit sterile and single-use?

    Yes, the kit is supplied sterile and is intended for single-use only, meaning it should be discarded after one procedure to maintain sterility and prevent cross-contamination in clinical or surgical settings.

  • What regulatory clearance does the Gibbons Sterile Trocar Kit have?

    The device has received FDA 510(k) clearance under submission number K012198, with a determination of substantial equivalence, and is regulated as a Class II medical device under regulation number 876.5090.