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Nonpowered Neurosurgical Instrument

by United States Surgical, A Division of Tyco Healthc

510(k) K953173

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 NumberK953173 Date3 Oct 1995ClearedStatusActive

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  • Withdrawn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
GWG
Device Class
Class II
Regulation
21 CFR Part 882.1480
Advisory Committee
Neurology
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 Nonpowered Neurosurgical Instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It is classified as a device under 21 CFR 882.4535. The device is used in neurosurgical procedures and is a nonpowered instrument.

The Nonpowered Neurosurgical Instrument is supplied by United States Surgical, A Division of Tyco Healthc, and has been granted FDA 510K clearance under the number K953173. The device is regulated under the product code GWG and has a regulation number of 882.1480. It is a nonpowered, non-sterile instrument, and its storage and use are subject to the manufacturer's instructions.

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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 Nonpowered Neurosurgical Instrument used for?

    The Nonpowered Neurosurgical Instrument is used in neurosurgical procedures to cut, hold, or manipulate tissue.

  • Is the Nonpowered Neurosurgical Instrument sterile?

    The Nonpowered Neurosurgical Instrument is a non-sterile instrument, and its storage and use are subject to the manufacturer's instructions.

  • What regulatory clearance has the Nonpowered Neurosurgical Instrument received?

    The Nonpowered Neurosurgical Instrument has been granted FDA 510K clearance under the number K953173.