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Tri-Staple 2.0 SIGCIR21MTORVIL

by Covidien LP

Tri-Staple 2.0 SIGCIR21MTORVIL is a Class II device made by Covidien LP, cleared under FDA 510(k) K253527 on 1 Jul 2026 (1 earlier submission) and listed in FDA GUDID since 9 Aug 2026 (UDI-DI 10884521703827), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884521703827 UDI-DI Date9 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK253527 Date1 Jul 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253527 decided 1 Jul 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521703827 listed 9 Aug 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182475
  2. Cleared FDA 510(k) K253527
  3. Listed FDA GUDID 10884521703827

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tri-Staple 2.0
Generic name
Surgical staple loading unit, cutting
Model / reference
SIGCIR21MTORVIL
Primary DI / UDI-DI
10884521703827
510(k) Number
FDA product code
GAG, GDW
GMDN term
Surgical staple loading unit, cutting
Device class
Class II
Regulation number
878.4740, 878.4750
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 90 Centimeter
Outer Diameter — 21 Millimeter

Related devices

Cleared under the same submission (K182475)

and 2 more cleared under K182475

Cleared under the same submission (K253527)

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
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)