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Trexon SY691P

by Covidien LP

Trexon SY691P is a Class II device made by Covidien LP, cleared under FDA 510(k) K253530 on 28 May 2026 and listed in FDA GUDID since 10 Oct 2026 (UDI-DI 10884521840706), 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

510(k) K253530

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 Number10884521840706 UDI-DI Date10 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK253530 Date28 May 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253530 decided 28 May 2026 Active
  • FDA GUDID UDI-DI 10884521840706 listed 10 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253530
  2. Listed FDA GUDID 10884521840706

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trexon
Generic name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Model / reference
SY691P
Primary DI / UDI-DI
10884521840706
510(k) Number
FDA product code
GAM
GMDN term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Device class
Class II
Regulation number
878.4493
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Length — 30 Inch

Related devices

Cleared under the same submission (K253530)

and 8 more cleared under K253530

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
  • Manufacturing date
Other properties (8, all answered No)