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DemeSILK SK266012F7P

by DemeTECH Corp

DemeSILK SK266012F7P is a Class II device made by DemeTECH Corp, cleared under FDA 510(k) K023029 on 25 Nov 2002, registered in EUDAMED and listed in FDA GUDID since 19 Jun 2019 (UDI-DI 10652927248699), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K023029

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10652927248699 UDI-DI Date19 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK023029 Date25 Nov 2002DecidedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K023029 decided 25 Nov 2002 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 10652927248699 listed 19 Jun 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K023029
  2. Listed FDA GUDID 10652927248699

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
DemeSILK
Generic name
Silk suture
Model / reference
SK266012F7P
Primary DI / UDI-DI
10652927248699
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)