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Olympus A22042A

by Olympus Winter & Ibe GmbH

Ref A22042A

Olympus A22042A is a device classified as Class IIa in the EU and Class II in the US made by Olympus Winter & Ibe GmbH, registered in EUDAMED on 11 Sep 2026 (Basic UDI-DI B-04042761020985), cleared under FDA 510(k) K931994 on 17 Feb 1994 (1 earlier submission) and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 04042761020985), active as of 23 Oct 2026. 18 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

18 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K931994

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042761020985 Basic UDI-DI 04042761020985UDI-DIDate11 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042761020985 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK931994 Date17 Feb 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042761020985 registered 11 Sep 2026 Active
  • FDA 510(k) K931994 decided 17 Feb 1994 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04042761020985 listed 21 Sep 2016 Listed

Recalls

18 recalls · 18 ongoing · FDA

  • 18 recalls, same reason

    • Ongoing Z-1445-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1455-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1452-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1440-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1450-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1442-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1439-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1444-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1453-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1456-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1441-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1451-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1448-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1457-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1443-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1446-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1438-2026 FDA Class II initiated 11 Nov 2025
    • Ongoing Z-1447-2026 FDA Class II initiated 11 Nov 2025

    Complaints of the ceramic tip of the resection sheath breaking have been received.

Timeline

22 dated events

  1. Recall initiated FDA recalls Z-1456-2026
  2. Recall initiated FDA recalls Z-1441-2026
  3. Recall initiated FDA recalls Z-1451-2026
  4. Recall initiated FDA recalls Z-1448-2026
  5. Recall initiated FDA recalls Z-1457-2026
  6. Recall initiated FDA recalls Z-1443-2026
  7. Recall initiated FDA recalls Z-1446-2026
  8. Recall initiated FDA recalls Z-1438-2026
  9. Recall initiated FDA recalls Z-1447-2026
  10. Registered EUDAMED B-04042761020985

12 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Resection sheath, 26 Fr. EUDAMED
Olympus GUDID
Generic name
Endoscope sheath, reusable
Model / Ref / Catalog
A22042A
Primary DI / UDI-DI
04042761020985
Basic UDI-DI
B-04042761020985
FDA product code
FJL, HIH
EMDN code
Z12020707 Resectoscopes
GMDN term
Endoscope sheath, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500, 884.1690
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Endoscope sheath, reusable

Cleared under the same submission (K931994)

and 7 more cleared under K931994

Cleared under the same submission (K931995)

and 7 more cleared under K931995

Similar devices in this category

Other devices filed under GENITOURINARY ENDOSCOPY INSTRUMENTS.

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)