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Wound Protector

by Covidien, Formerly US Surgical A Divison of Tyco H

510(k) K120061

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 NumberK120061 Date27 Mar 2012ClearedStatusActive

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  • Withdrawn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
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Wound Protector is a surgical device classified under the product code GCJ, designed to facilitate access to the abdominal cavity during surgery. It is intended to retract an incision atraumatically, providing maximum exposure of the abdominal cavity while minimizing incision size. This aids in surgical procedures within the gastroenterology and urology specialties, ensuring clear and unobstructed access to the operative field.

This device is supplied as a single-use item and is regulated under FDA 510(k) clearance with the reference number K120061. It was determined substantially equivalent to a predicate device and received clearance on March 27, 2012. The Wound Protector is intended for use in sterile surgical environments and adheres to standard surgical safety and sterility protocols.

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Questions

AI-generated answers, 1 Oct 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 Wound Protector designed to do during surgery?

    The Wound Protector is engineered to retract an abdominal incision gently (atraumatically) while maximizing exposure of the operative field. This helps surgeons perform procedures in gastroenterology and urology with minimal incision disruption, ensuring unobstructed access to the abdominal cavity.

  • Is the Wound Protector reusable or intended for single-use?

    The Wound Protector is explicitly supplied as a single-use device. This design choice aligns with standard surgical safety protocols, reducing the risk of cross-contamination and ensuring sterility for each procedure.

  • What specialties benefit most from using the Wound Protector?

    The device is primarily intended for use in gastroenterology and urology surgeries. Its atraumatic retraction and clear exposure are particularly advantageous for procedures requiring precise access to the abdominal cavity in these specialties.

  • How is the Wound Protector regulated and cleared?

    The Wound Protector received FDA clearance under the 510(k) pathway (reference K120061) and was deemed substantially equivalent to a predicate device. Clearance was granted on March 27, 2012, following review by the Gastroenterology/Urology (GU) advisory committee.

  • What sterility and handling precautions should be taken with the Wound Protector?

    The Wound Protector is intended for sterile surgical environments only. It must be handled as a single-use item, adhering to standard surgical sterility protocols to maintain its integrity and prevent contamination before and during use.