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Hi-Q Hand Instruments, Ob/Gyn Use

by Olympus America, Inc.

510(k) K944200

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 NumberK944200 Date15 Sep 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  • Withdrawn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
HET
Device Class
Class II
Regulation
21 CFR Part 884.1720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Hi-Q Hand Instruments are medical devices designed for obstetrics and gynecology procedures. These instruments are classified as laparoscopic gynecologic accessories and are intended for use in surgical applications within the OB/GYN specialty.

The device is supplied as a non-sterile, reusable instrument and is not MRI compatible. It is stored at room temperature and has FDA 510(k) clearance with the product code HET, registered under the regulation number 884.1720.

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Questions

AI-generated answers, 27 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 are Hi-Q Hand Instruments used for?

    Hi-Q Hand Instruments are medical devices designed for obstetrics and gynecology procedures, specifically classified as laparoscopic gynecologic accessories for surgical applications within the OB/GYN specialty.

  • How are Hi-Q Hand Instruments supplied and what is their sterility status?

    The instruments are supplied as non-sterile, reusable devices. They require appropriate sterilization before each use according to standard medical protocols.

  • Are Hi-Q Hand MRI compatible?

    No, Hi-Q Hand Instruments are not MRI compatible and should not be used in MRI environments due to potential interference with the imaging process.

  • What is the regulatory status of Hi-Q Hand Instruments?

    The devices have FDA 510(k) clearance with product code HET, registered under regulation number 884.1720, and are classified as substantially equivalent to predicate devices.

  • How should Hi-Q Hand Instruments be stored?

    These instruments should be stored at room temperature in a clean, dry environment to maintain their functionality and extend their lifespan as reusable medical devices.