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DemeSILK SK3600

by DemeTECH Corp

DemeSILK SK3600 is a Class II device made by DemeTECH Corp, cleared under FDA 510(k) K023029 on 25 Nov 2002 and listed in FDA GUDID since 18 Jul 2019 (UDI-DI 10652927182429), 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) K023029

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 Number10652927182429 UDI-DI Date18 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK023029 Date25 Nov 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K023029 decided 25 Nov 2002 Active
  • FDA GUDID UDI-DI 10652927182429 listed 18 Jul 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K023029
  2. Listed FDA GUDID 10652927182429

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DemeSILK
Generic name
Silk suture
Model / reference
SK3600
Primary DI / UDI-DI
10652927182429
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 (K023029)

and 8 more cleared under K023029

Similar devices in this category

Other devices filed under Silk suture.

Other devices from DemeTECH Corp

See all devices from DemeTECH Corp →

Properties

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