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Nezhat-Dorsey Laparoscopic Hand Instruments

by American Hydro-Surgical Instruments, Inc. 2 variants

510(k) K950507

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 NumberK950507 Date6 Mar 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  • Withdrawn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
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Nezhat-Dorsey Laparoscopic Hand Instruments are medical devices designed for use in laparoscopic surgical procedures. These instruments are intended for use in general and plastic surgery applications, providing surgeons with specialized tools for minimally invasive operations.

The device is supplied as a non-sterile, reusable instrument and is not MRI compatible. It is authorized under FDA 510(k) clearance number K950507 with product code GEI. The instruments should be stored according to the manufacturer's instructions and are approved for use in clinical settings.

Other devices from American Hydro-Surgical Instruments, Inc.

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Questions

AI-generated answers, 6 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 are the Nezhat-Dorsey Laparoscopic Hand Instruments used for?

    These instruments are designed for use in laparoscopic surgical procedures, specifically for general and plastic surgery applications. They provide surgeons with specialized tools for performing minimally invasive operations.

  • Are the Nezhat-Dorsey Laparoscopic Hand Instruments single-use or reusable?

    The Nezhat-Dorsey Laparoscopic Hand Instruments are supplied as non-sterile, reusable instruments. They can be used multiple times following proper sterilization according to the manufacturer's instructions.

  • What is the regulatory status of these instruments?

    The Nezhat-Dorsey Laparoscopic Hand Instruments are authorized under FDA 510(k) clearance number K950507 with product code GEI. They have been determined to be substantially equivalent to predicate devices.

  • How should these instruments be stored?

    The instruments should be stored according to the manufacturer's instructions. Proper storage conditions help maintain the integrity and functionality of the instruments between uses.