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Foot Switch F/S

by VIOL Co., Ltd.

Foot Switch F/S is an electrosurgical system (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by VIOL Co., Ltd., cleared under FDA 510(k) K172023 on 13 Oct 2017 and listed in FDA GUDID since 2 Apr 2018 (UDI-DI 08809502330033), 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) K172023

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 Number08809502330033 UDI-DI Date2 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172023 Date13 Oct 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172023 decided 13 Oct 2017 Active
  • FDA GUDID UDI-DI 08809502330033 listed 2 Apr 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172023
  2. Listed FDA GUDID 08809502330033

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Foot Switch
Generic name
Electrosurgical system
Model / reference
F/S
Primary DI / UDI-DI
08809502330033
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Electrosurgical system.

Other devices from VIOL Co., Ltd.

  • Scarlet Pro (Scarlet Pro)

    Class II
  • Cellinew

    Class II
  • Foot Switch F/S-Hrf-Blue

    Class II
  • Scarlet Srf

    Class II

See all devices from VIOL Co., Ltd. →

Properties

  • Serial number
Other properties (14, all answered No)