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Surgical Retractor

by Advanced Surgical, Inc.

510(k) K921287

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 NumberK921287 Date4 Mar 1993ClearedStatusActive

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  • Withdrawn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, 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 Surgical Retractor is a device used to retract tissue and provide exposure during surgical procedures. It is designed to assist surgeons in accessing the surgical site. The device is substantially equivalent to other retractors on the market.

The Surgical Retractor is supplied as a single device and is intended for use in various surgical settings. It has been cleared under the FDA 510K clearance type and has been assigned the product code GCJ. The device is available for use in gastroenterology and urology applications.

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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 Surgical Retractor used for?

    The Surgical Retractor is used to retract tissue and provide exposure during surgical procedures, assisting surgeons in accessing the surgical site.

  • Is the Surgical Retractor supplied sterile?

    The device data does not specify if the Surgical Retractor is supplied sterile, it is recommended to follow proper sterilization procedures before use.

  • What are the intended applications of the Surgical Retractor?

    The Surgical Retractor is intended for use in various surgical settings, including gastroenterology and urology applications.