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Silkro

by Hironic Co., Ltd.

Ref SK-USM-EN02Model GENTLO/SILKRO

Silkro is a device classified as Class IIb in the EU and Class II in the US made by Hironic Co., Ltd., registered in EUDAMED on 8 Sep 2026 (Basic UDI-DI B-08800016213027), cleared under FDA 510(k) K233123 on 24 Jun 2024 (1 earlier submission) and listed in FDA GUDID since 28 Jun 2024 (UDI-DI 08800016213027), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233123

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800016213027 Basic UDI-DI 08800016213027UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800016213027 UDI-DI Date28 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK233123 Date24 Jun 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800016213027 registered 8 Sep 2026 Active
  • FDA 510(k) K233123 decided 24 Jun 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08800016213027 listed 28 Jun 2024 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K210084
  2. Cleared FDA 510(k) K233123
  3. Listed FDA GUDID 08800016213027
  4. Registered EUDAMED B-08800016213027

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  • Withdrawn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

Generic name
Electrosurgical system
Device name
Electrosurgical System, General Purpose
Model / reference
GENTLO/SILKRO EUDAMED
SK-USM-EN02 EUDAMED
SILKRO GUDID
Primary DI / UDI-DI
08800016213027
Basic UDI-DI
B-08800016213027
510(k) Number
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Electrosurgical system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Türkiye
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
GENTLO/SILKRO
SK-USM-EN02
GUDID
SILKRO
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Electrosurgical system

Cleared under the same submission (K233123)

and 8 more cleared under K233123

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

Other devices from Hironic Co., Ltd.

See all devices from Hironic Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)