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Integra 3

by Research Instruments, Ltd. 11 variants

Integra 3 (6-54-100) is a Class II device made by Research Instruments, Ltd., cleared under FDA 510(k) K003142 on 22 Nov 2000 and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 05060170185056), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K003142

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060170185056 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK003142 Date22 Nov 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K003142 decided 22 Nov 2000 Active
  • FDA GUDID UDI-DI 05060170185056 listed 17 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1584-2016 FDA Class II initiated 11 Mar 2016

    The units have been fitted with a potentially faulty power supply cable.

Timeline

3 dated events

  1. Cleared FDA 510(k) K003142
  2. Recall initiated FDA recalls Z-1584-2016
  3. Listed FDA GUDID 05060170185056

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Assisted reproduction electromechanical micromanipulator
Model / Ref / Catalog
INTEGRA 3 micromanipulation System with Thermosafe, 6-54-100
Primary DI / UDI-DI
05060170185056
510(k) Number
FDA product code
MQJ
GMDN term
Assisted reproduction electromechanical micromanipulator
Device class
Class II
Regulation number
884.6150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Assisted reproduction electromechanical micromanipulator

Cleared under the same submission (K003142)

and 8 more cleared under K003142

Similar devices

Other devices filed under FDA product code MQJ (MICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION).

Other devices from Research Instruments, Ltd.

See all devices from Research Instruments, Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)