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Signia SIGMRET

by Covidien LP

Ref SIGMRET

Signia SIGMRET is a device classified as Class I in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI 0763000B00001076Z), cleared under FDA 510(k) K240881 on 1 Nov 2024 (2 earlier submissions) and listed in FDA GUDID since 24 Jul 2017 (UDI-DI 10884521543881), active as of 24 Oct 2026. 14 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

13 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K240881

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00001076Z Basic UDI-DI 10884521543881UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240881 Date1 Nov 2024DecidedStatusActive
United StatesGUDID listing GUDID Number10884521543881 UDI-DI Date24 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00001076Z registered 1 Jul 2026 Active
  • FDA 510(k) K240881 decided 1 Nov 2024 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10884521543881 listed 24 Jul 2017 Listed

Recalls

14 recalls · 13 ongoing · FDA

    • Ongoing Z-1228-2023 FDA Class II initiated 25 Jan 2023

    Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.

  • 12 recalls, same reason

    • Ongoing Z-1834-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1828-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1826-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1832-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1827-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1836-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1833-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1835-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1830-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1825-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1829-2019 FDA Class II initiated 17 May 2019
    • Ongoing Z-1831-2019 FDA Class II initiated 17 May 2019

    The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

    • Terminated Z-1237-2018 FDA Class II initiated 13 Dec 2017

    Product reportedly shutting down during use.

Timeline

19 dated events

  1. Recall initiated FDA recalls Z-1833-2019
  2. Recall initiated FDA recalls Z-1835-2019
  3. Recall initiated FDA recalls Z-1830-2019
  4. Recall initiated FDA recalls Z-1825-2019
  5. Recall initiated FDA recalls Z-1829-2019
  6. Recall initiated FDA recalls Z-1831-2019
  7. Cleared FDA 510(k) K201672
  8. Recall initiated FDA recalls Z-1228-2023
  9. Cleared FDA 510(k) K240881
  10. Registered EUDAMED 0763000B00001076Z

9 earlier events are in the sections above.

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
Signia
Generic name
Surgical screwdriver, reusable
Device name
Signia Stapler
Model / reference
SIGMRET
Primary DI / UDI-DI
10884521543881
Basic UDI-DI
0763000B00001076Z
Direct marketing DI
10884521543881
510(k) Number
FDA product code
GDW
EMDN code
H020380 Staplers, videosurgery - accessories
GMDN term
Surgical screwdriver, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4750
EU registration type
Standard device
EU market of registration
Netherlands
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 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: Surgical screwdriver, reusable

Cleared under the same submission (K160176)

and 8 more cleared under K160176

Cleared under the same submission (K201672)

and 5 more cleared under K201672

Similar devices in this category

Other devices filed under STAPLERS FOR VIDEOSURGERY.

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)