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ForceTriad FT6009

by Covidien LP

Part of a family of 6 devices: see the family page

Ref FT6009

ForceTriad FT6009 is a device classified as Class I in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 26 Aug 2026 (Basic UDI-DI 0763000B000016177), cleared under FDA 510(k) K110268 on 31 May 2011 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884524002903), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K110268

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000016177 Basic UDI-DI 10884524002903UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884524002903 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK110268 Date31 May 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000016177 registered 26 Aug 2026 Active
  • FDA 510(k) K110268 decided 31 May 2011 Active
  • FDA GUDID UDI-DI 10884524002903 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K110268
  2. Listed FDA GUDID 10884524002903
  3. Registered EUDAMED 0763000B000016177

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ForceTriadTM EUDAMED
ForceTriad GUDID
Generic name
Foot-switch, electrical
Device name
Bipolar Footswitch
Model / reference
FT6009
Primary DI / UDI-DI
10884524002903
Basic UDI-DI
0763000B000016177
510(k) Number
FDA product code
GEI
EMDN code
K020180 Single- and bipolar devices, single use - accessories
GMDN term
Foot-switch, electrical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 15 Feet

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Foot-switch, electrical

Cleared under the same submission (K110268)

and 3 more cleared under K110268

Similar devices in this category

Other devices filed under SINGLE- AND BIPOLAR DEVICES, SINGLE USE - ACCESSORIES.

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

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)