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Percutaneous Retractor Kit

by Applied Urology, Inc.

510(k) K912903

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 NumberK912903 Date16 Aug 1991ClearedStatusActive

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  • Withdrawn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, 22 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 Percutaneous Retractor Kit is a medical device designed for use in urological procedures. It provides retraction during percutaneous surgical interventions, allowing for better access and visualization of the surgical site.

The device is supplied as a kit and is intended for single-use. It has received FDA 510(k) clearance with product code GCJ and was cleared on August 16, 1991. The device is manufactured by Applied Urology, Inc. and is not indicated for MRI use.

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Questions

AI-generated answers, 22 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 Percutaneous Retractor Kit used for?

    The Percutaneous Retractor Kit is designed for use in urological procedures to provide retraction during percutaneous surgical interventions, allowing for better access and visualization of the surgical site.

  • Is the Percutaneous Retractor Kit reusable or single-use?

    The Percutaneous Retractor Kit is supplied as a kit and is intended for single-use only. It should not be reused on multiple patients.

  • What regulatory approvals does the Percutaneous Retractor Kit have?

    The Percutaneous Retractor Kit has received FDA 510(k) clearance with product code GCJ and was cleared on August 16, 1991. It is manufactured by Applied Urology, Inc.

  • Can the Percutaneous Retractor Kit be used in MRI procedures?

    No, the Percutaneous Retractor Kit is not indicated for MRI use. It should only be used in accordance with its intended purpose in urological procedures.