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Signia SIGLU60A

by Covidien LP

Signia SIGLU60A is a Class II device made by Covidien LP, cleared under FDA 510(k) K160176 on 26 Apr 2016 and listed in FDA GUDID since 26 May 2017 (UDI-DI 10884521543508), active as of 23 Oct 2026. 14 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

13 ongoing

This device is named in the recall

Documents

510(k) K160176

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 Number10884521543508 UDI-DI Date26 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160176 Date26 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160176 decided 26 Apr 2016 Active
  • FDA GUDID UDI-DI 10884521543508 listed 26 May 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

16 dated events

  1. Recall initiated FDA recalls Z-1832-2019
  2. Recall initiated FDA recalls Z-1827-2019
  3. Recall initiated FDA recalls Z-1836-2019
  4. Recall initiated FDA recalls Z-1833-2019
  5. Recall initiated FDA recalls Z-1835-2019
  6. Recall initiated FDA recalls Z-1830-2019
  7. Recall initiated FDA recalls Z-1825-2019
  8. Recall initiated FDA recalls Z-1829-2019
  9. Recall initiated FDA recalls Z-1831-2019
  10. Recall initiated FDA recalls Z-1228-2023

6 earlier events are in the sections above.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Signia
Generic name
Endoscopic manual linear cutting stapler, single-use
Model / reference
SIGLU60A
Primary DI / UDI-DI
10884521543508
510(k) Number
FDA product code
GDW
GMDN term
Endoscopic manual linear cutting stapler, single-use
Device class
Class II
Regulation number
878.4750
GUDID distribution status
In Commercial Distribution
Size
Length — 60 Millimeter

Related devices

Category: Endoscopic manual linear cutting stapler, single-use

Cleared under the same submission (K160176)

and 8 more cleared under K160176

Similar devices in this category

Other devices filed under Endoscopic manual linear cutting stapler, 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
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)