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Disposable Skin Retractor

by Cimarron Instruments, Inc.

510(k) K801151

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 NumberK801151 Date20 May 1980ClearedStatusActive

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  • Withdrawn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
GZT
Device Class
Class II
Regulation
21 CFR Part 882.4800
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

A disposable skin retractor is a self-retaining retractor for neurosurgery. It is classified as a Class II medical device under regulation number 882.4800.

The device is supplied sterile and intended for single-use. It received FDA 510(k) clearance (K801151) on May 20, 1980, and is manufactured by Cimarron Instruments, Inc. in McHenry, Illinois.

Other devices from Cimarron Instruments, Inc.

Questions

AI-generated answers, 24 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 Disposable Skin Retractor used for?

    The Disposable Skin Retractor is a self-retaining retractor specifically designed for use in neurosurgical procedures. It helps to hold back tissues and organs to provide access and visibility during surgery.

  • Is the Disposable Skin Retractor supplied sterile?

    Yes, the Disposable Skin Retractor is supplied in a sterile condition to maintain aseptic surgical conditions and reduce the risk of infection during procedures.

  • Can the Disposable Skin Retractor be reused?

    No, the Disposable Skin Retractor is intended for single-use only. After use, it should be properly disposed of according to medical waste protocols to ensure safety and prevent cross-contamination.

  • What is the regulatory status of the Disposable Skin Retractor?

    The Disposable Skin Retractor has received FDA 510(k) clearance (K801151) on May 20, 1980, and is classified as a Class II medical device under regulation number 882.4800.