Skip to content

Sutumed DST010MC260

by Unilene Sac

Sutumed DST010MC260 is a Class II device made by Unilene Sac, cleared under FDA 510(k) K123034 on 28 May 2013 and listed in FDA GUDID since 9 Jan 2023 (UDI-DI 07757093028734), 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) K123034

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 Number07757093028734 UDI-DI Date9 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123034 Date28 May 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123034 decided 28 May 2013 Active
  • FDA GUDID UDI-DI 07757093028734 listed 9 Jan 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123034
  2. Listed FDA GUDID 07757093028734

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sutumed
Generic name
Silk suture
Model / reference
DST010MC260
Primary DI / UDI-DI
07757093028734
510(k) Number
FDA product code
GAP
GMDN term
Silk suture
Device class
Class II
Regulation number
878.5030
GUDID distribution status
In Commercial Distribution

Related devices

Category: Silk suture

Cleared under the same submission (K123034)

and 8 more cleared under K123034

Similar devices

Also classified as Silk suture.

Similar devices in this category

Other devices filed under Silk suture.

Other devices from Unilene Sac

See all devices from Unilene Sac →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)