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Versaport V2 Bladeless Optical Trocar

by Covidien, Formerly US Surgical A Divison of Tyco H

510(k) K112349

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

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 · Special NumberK112349 Date1 Sep 2011ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-1467-2013 FDA Class II initiated 6 May 2013
    • Terminated Z-1472-2013 FDA Class II initiated 6 May 2013
    • Terminated Z-1469-2013 FDA Class II initiated 6 May 2013
    • Terminated Z-1470-2013 FDA Class II initiated 6 May 2013
    • Terminated Z-1471-2013 FDA Class II initiated 6 May 2013
    • Terminated Z-1468-2013 FDA Class II initiated 6 May 2013

    Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar
510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Versaport V2 Bladeless Optical Trocar is a device used to create and maintain a port of entry in endoscopic procedures. It features a spring-loaded parabolic entry shield that helps dilate tissue and covers the blade upon entry into the abdominal cavity to potentially reduce injury to internal structures.

This trocar is intended for use in gynecologic, general, thoracic, and urologic endoscopic procedures and may be used with or without visualization. It is supplied by Covidien, Formerly US Surgical A Division of Tyco H and has FDA 510(k) clearance with product code GCJ.

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Questions

AI-generated answers, 28 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 Versaport V2 Bladeless Optical Trocar used for?

    The Versaport V2 Bladeless Optical Trocar is designed to create and maintain a port of entry in endoscopic procedures. It is intended for use in gynecologic, general, thoracic, and uroscopic procedures and may be used with or without visualization.

  • How is the Versaport V2 Bladeless Optical Trocar supplied?

    The Versaport V2 Bladeless Optical Trocar is supplied by Covidien, Formerly US Surgical A Division of Tyco H. The device is manufactured and distributed by this company for medical use in endoscopic procedures.

  • What are the key features of the Versaport V2 Bladeless Optical Trocar?

    The Versaport V2 Bladeless Optical Trocar features a spring-loaded parabolic entry shield that helps dilate tissue and covers the blade upon entry into the abdominal cavity. This design is intended to potentially reduce injury to internal structures during endoscopic procedures.

  • What is the regulatory status of the Versaport V2 Bladeless Optical Trocar?

    The Versaport V2 Bladeless Optical Trocar has FDA 510(k) clearance with product code GCJ. It was received by the FDA on August 16, 2011, and cleared on September 1, 2011, with a decision code of SESE (Substantially Equivalent).