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Footswitch

by Boston Scientific Neuromodulation Corporation

Ref FS-1

Footswitch (FS-1) is a radio-frequency ablation system (EU MDR Class I; FDA Class II) made by Boston Scientific Neuromodulation, registered in EUDAMED on 2 Apr 2026 (Basic UDI-DI 01915060000000000000080MQ) and listed in FDA GUDID since 21 Aug 2017 (UDI-DI 00813250011746), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000080MQ Basic UDI-DI 00813250011746UDI-DIDate2 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813250011746 UDI-DI Date21 Aug 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01915060000000000000080MQ registered 2 Apr 2026 Active
  • FDA GUDID UDI-DI 00813250011746 listed 21 Aug 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00813250011746
  2. Registered EUDAMED 01915060000000000000080MQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Radio-frequency ablation system
Device name
Footswitch
Model / reference
FS-1
Primary DI / UDI-DI
00813250011746
Basic UDI-DI
01915060000000000000080MQ
FDA product code
GXI, GXD
EMDN code
K020380 Devices for surgery with radiofrequency generator, single-use - accessories
GMDN term
Radio-frequency ablation system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4725, 882.4400
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

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.

Manufacturer details

EUDAMED SRN
US-MF-000004703
Authorised representative
Boston Scientific Limited IE-AR-000003840

Related devices

Category: Radio-frequency ablation system

Similar devices in this category

Other devices filed under DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES.

Other devices from Boston Scientific Neuromodulation

See all devices from Boston Scientific Neuromodulation →

Properties

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