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Edintrak 4031-O

by Stryker GmbH

Edintrak 4031-O is a Class II device made by Stryker GmbH, cleared under FDA 510(k) K940230 on 12 Dec 1994 and listed in FDA GUDID since 30 May 2017 (UDI-DI 07613327362855), active as of 12 Nov 2026. 13 FDA recalls are 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

13 closed

Documents

510(k) K940230

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613327362855 UDI-DI Date30 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK940230 Date12 Dec 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K940230 decided 12 Dec 1994 Active
  • FDA GUDID UDI-DI 07613327362855 listed 30 May 2017 Listed

Recalls

13 recalls · FDA

  • 13 recalls, same reason

    • Terminated Z-2414-2019 FDA Class II initiated 25 Jul 2019
    • Terminated Z-2421-2019 FDA Class II initiated 25 Jul 2019
    • Terminated Z-2413-2019 FDA Class II initiated 25 Jul 2019
    • Terminated Z-2420-2019 FDA Class II initiated 25 Jul 2019
    • Terminated Z-2416-2019 FDA Class II initiated 25 Jul 2019
    • Terminated Z-2412-2019 FDA Class II initiated 25 Jul 2019
    • Terminated Z-2418-2019 FDA Class II initiated 25 Jul 2019
    • Terminated Z-2419-2019 FDA Class II initiated 25 Jul 2019
    • Terminated Z-2417-2019 FDA Class II initiated 25 Jul 2019
    • Terminated Z-2423-2019 FDA Class II initiated 25 Jul 2019
    • Terminated Z-2415-2019 FDA Class II initiated 25 Jul 2019
    • Terminated Z-2422-2019 FDA Class II initiated 25 Jul 2019
    • Terminated Z-2424-2019 FDA Class II initiated 25 Jul 2019

    The seal integrity of the sterile bag containing the kits may be compromised.

Timeline

15 dated events

  1. Recall initiated FDA recalls Z-2420-2019
  2. Recall initiated FDA recalls Z-2416-2019
  3. Recall initiated FDA recalls Z-2412-2019
  4. Recall initiated FDA recalls Z-2418-2019
  5. Recall initiated FDA recalls Z-2419-2019
  6. Recall initiated FDA recalls Z-2417-2019
  7. Recall initiated FDA recalls Z-2423-2019
  8. Recall initiated FDA recalls Z-2415-2019
  9. Recall initiated FDA recalls Z-2422-2019
  10. Recall initiated FDA recalls Z-2424-2019

5 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Edintrak
Generic name
Rigid endoscope obturator
Model / Ref / Catalog
4031-O
Primary DI / UDI-DI
07613327362855
510(k) Number
FDA product code
HRX
GMDN term
Rigid endoscope obturator
Device class
Class II
Regulation number
888.1100
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Rigid endoscope obturator

Cleared under the same submission (K940230)

and 8 more cleared under K940230

Similar devices in this category

Other devices filed under Rigid endoscope obturator.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)