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Auto Suture OMS-T10SB

by Covidien LP

Ref OMST10SB

Auto Suture OMS-T10SB is a device classified as Class IIa in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 12 Oct 2026 (Basic UDI-DI 0763000B000055988), cleared under FDA 510(k) K924011 on 9 Jul 1993 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884521081086), active as of 23 Oct 2026. 7 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

7 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K924011

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000055988 Basic UDI-DI 10884521081086UDI-DIDate12 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521081086 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK924011 Date9 Jul 1993DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000055988 registered 12 Oct 2026 Active
  • FDA 510(k) K924011 decided 9 Jul 1993 Active
  • FDA GUDID UDI-DI 10884521081086 listed 24 Sep 2016 Listed

Recalls

7 recalls · 7 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-1465-2024 FDA Class II initiated 28 Feb 2024
    • Ongoing Z-1468-2024 FDA Class II initiated 28 Feb 2024
    • Ongoing Z-1471-2024 FDA Class II initiated 28 Feb 2024
    • Ongoing Z-1467-2024 FDA Class II initiated 28 Feb 2024
    • Ongoing Z-1470-2024 FDA Class II initiated 28 Feb 2024
    • Ongoing Z-1469-2024 FDA Class II initiated 28 Feb 2024
    • Ongoing Z-1466-2024 FDA Class II initiated 28 Feb 2024

    The potential for trocar seal disengagement when using mesh products incorrectly with the device.

Timeline

10 dated events

  1. Cleared FDA 510(k) K924011
  2. Listed FDA GUDID 10884521081086
  3. Recall initiated FDA recalls Z-1465-2024
  4. Recall initiated FDA recalls Z-1468-2024
  5. Recall initiated FDA recalls Z-1471-2024
  6. Recall initiated FDA recalls Z-1467-2024
  7. Recall initiated FDA recalls Z-1470-2024
  8. Recall initiated FDA recalls Z-1469-2024
  9. Recall initiated FDA recalls Z-1466-2024
  10. Registered EUDAMED 0763000B000055988

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
AutosutureTM EUDAMED
Auto Suture GUDID
Generic name
Surgical balloon dissector
Device name
Auto Suture™ Structural Balloon Trocar
Model / reference
OMST10SB EUDAMED
OMS-T10SB GUDID
Primary DI / UDI-DI
10884521081086
Basic UDI-DI
0763000B000055988
510(k) Number
FDA product code
GCJ
EMDN code
K01020101 Minimally invasive surgery dissectors, single-use
GMDN term
Surgical balloon dissector
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 10 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
OMST10SB
GUDID
OMS-T10SB
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: Surgical balloon dissector

Cleared under the same submission (K924011)

and 2 more cleared under K924011

Similar devices in this category

Other devices filed under MINIMALLY INVASIVE SURGERY DISSECTORS, SINGLE-USE.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)