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Syneture VLOCN0346

by Covidien LP

Syneture VLOCN0346 is a Class II device made by Covidien LP, cleared under FDA 510(k) K103052 on 10 Nov 2010 and listed in FDA GUDID since 24 Mar 2018 (UDI-DI 10884521762527), 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) K103052

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 Number10884521762527 UDI-DI Date24 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103052 Date10 Nov 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103052 decided 10 Nov 2010 Active
  • FDA GUDID UDI-DI 10884521762527 listed 24 Mar 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103052
  2. Listed FDA GUDID 10884521762527

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Syneture
Generic name
Barbed polyester suture, non-antimicrobial
Model / reference
VLOCN0346
Primary DI / UDI-DI
10884521762527
510(k) Number
FDA product code
GAT
GMDN term
Barbed polyester suture, non-antimicrobial
Device class
Class II
Regulation number
878.5000
GUDID distribution status
In Commercial Distribution
Size
Length — 9 Inch

Related devices

Category: Barbed polyester suture, non-antimicrobial

Cleared under the same submission (K103052)

and 8 more cleared under K103052

Similar devices

Other devices filed under FDA product code GAT (SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE).

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)