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Halyard 88760

by O&M Halyard Inc.

Part of a family of 115 devices: see the family page

Ref 88760

Halyard 88760 is a device classified as Class I in the EU and Class II in the US made by O&M Halyard Inc., registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 06806517SP010SDP), cleared under FDA 510(k) K083234 on 25 Mar 2009 and listed in FDA GUDID since 15 Dec 2015 (UDI-DI 10680651887600), active as of 25 Oct 2026. 2 FDA recalls are linked to it.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083234

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number06806517SP010SDP Basic UDI-DI 10680651887600UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10680651887600 UDI-DI Date15 Dec 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083234 Date25 Mar 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 06806517SP010SDP registered 2 Sep 2026 Active
  • FDA 510(k) K083234 decided 25 Mar 2009 Active
  • FDA GUDID UDI-DI 10680651887600 listed 15 Dec 2015 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2520-2025 FDA Class II initiated 17 Jul 2025

    Surgical drape packs may have open seals, which may compromise the sterility of the product.

    • Ongoing Z-0983-2025 FDA Class II initiated 26 Nov 2024

    Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

Timeline

5 dated events

  1. Cleared FDA 510(k) K083234
  2. Listed FDA GUDID 10680651887600
  3. Recall initiated FDA recalls Z-0983-2025
  4. Recall initiated FDA recalls Z-2520-2025
  5. Registered EUDAMED 06806517SP010SDP

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Halyard
Generic name
General surgical procedure kit, non-medicated, single-use
Device name
Surgical Packs Sterile
Model / reference
88760
Primary DI / UDI-DI
10680651887600
Basic UDI-DI
06806517SP010SDP
510(k) Number
FDA product code
KKX
EMDN code
T020199 Surgical drapes - other
GMDN term
General surgical procedure kit, non-medicated, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4370
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: General surgical procedure kit, non-medicated, single-use

Cleared under the same submission (K083234)

and 8 more cleared under K083234

Similar devices in this category

Other devices filed under SURGICAL DRAPES - OTHER.

Other devices from O&M Halyard Inc.

See all devices from O&M Halyard Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)