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Consumable Tip

by VIOL Co., Ltd. 2 variants

Consumable Tip 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, registered in EUDAMED and listed in FDA GUDID since 23 Feb 2018 (UDI-DI 28809502330013), active as of 12 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 12 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172023

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Oct 2026.

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number28809502330013 UDI-DI Date23 Feb 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172023 Date13 Oct 2017DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K172023 decided 13 Oct 2017 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 28809502330013 listed 23 Feb 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K172023
  2. Listed FDA GUDID 28809502330013

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  • Withdrawn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

Generic name
Electrosurgical system
Model / reference
Consumable Tip
Primary DI / UDI-DI
28809502330013
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

Related devices

Category: Electrosurgical system

Cleared under the same submission (K172023)

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

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)