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Auto Suture OMST10BTSNL

by Covidien LP

Auto Suture OMST10BTSNL is a Class II device made by Covidien LP, cleared under FDA 510(k) K924011 on 9 Jul 1993 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 20884521539645), active as of 23 Oct 2026. 7 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

7 ongoing

This device is named in the recall

Documents

510(k) K924011

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20884521539645 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK924011 Date9 Jul 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K924011 decided 9 Jul 1993 Active
  • FDA GUDID UDI-DI 20884521539645 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

9 dated events

  1. Cleared FDA 510(k) K924011
  2. Listed FDA GUDID 20884521539645
  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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Auto Suture
Generic name
Surgical balloon dissector
Model / reference
OMST10BTSNL
Primary DI / UDI-DI
20884521539645
510(k) Number
FDA product code
GCJ
GMDN term
Surgical balloon dissector
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 10 Millimeter

Related devices

Category: Surgical balloon dissector

Cleared under the same submission (K924011)

and 2 more cleared under K924011

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, general & plastic surgery).

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
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)