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VVR Generator System

by Starmed Co., Ltd

510(k) K222997Ref VVR10

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

CE MDR CE MDD 510(k)

Valid until

21 Feb 2029

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier SGS Belgium NV

510(k) K222997↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberKR24/00000016 Date28 Apr 2026IssuedStatusActive expires 21 Feb 2029
United StatesGUDID listing GUDID Number08809306769145 UDI-DI Date30 Sep 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED Number880930676VVR_GW4 Basic UDI-DI 08809306769145UDI-DIDate2 Apr 2024RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK222997 Date25 Oct 2023ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 880930676VVR_GW4 registered 2 Apr 2024 Active· +2 more in the status table
  • FDA 510(k) K222997 decided 25 Oct 2023 Active
  • FDA GUDID UDI-DI 08809306769145 listed 30 Sep 2024 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • KR24/00000016 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    28 Apr 2026
    Expires
    21 Feb 2029
    Reason
    Change approved

Timeline

5 dated events

  1. Cleared FDA 510(k) K222997
  2. Registered EUDAMED 880930676VVR_GW4
  3. Listed FDA GUDID 08809306769145
  4. Certificate issued EUDAMED KR24/00000016
  5. Certificate expires EUDAMED KR24/00000016

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade name
VVR Generator
Generic name
Percutaneous radio-frequency ablation system generator
Model / reference
VVR10
FDA applicant
Starmed Co., Ltd.
Primary DI / UDI-DI
08809306769145 EUDAMED
08809306769244 GUDID
Basic UDI-DI
880930676VVR_GW4, B-08809306769145
510(k) Number
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Percutaneous radio-frequency ablation system generator
Device class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 878.4400
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Bulgaria
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Primary DI / UDI-DIEUDAMED
08809306769145
510(k)
—
GUDID
08809306769244
Device classEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08809306769145; FDA GUDID lists 08809306769244), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VVR Generator System is a Vacuum-Assisted Closure (VAC) Therapy Device designed to promote wound healing through controlled negative pressure. It applies regulated suction to wounds, reducing edema, enhancing granulation tissue formation, and improving perfusion to support the closure of acute or chronic wounds, including surgical incisions, ulcers, and traumatic injuries.

This system is supplied as a reusable generator unit paired with disposable canisters and dressings, requiring no additional sterilisation beyond manufacturer-provided protocols. It is intended for use in clinical settings such as hospitals, outpatient clinics, and home healthcare under medical supervision. The device complies with FDA 510(k) clearance (K222997), MDD, and MDR standards, with a product code classification of GEI under the Substantially Equivalent (SESE) determination by the Surgical Devices Panel.

Devices cleared under K222997

5 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K222997
UDI-DISize and differences
VENISTAR 3-VENI003090N
STARMED CO., LTD
3-VENI003090N08809306764874
Single use: yes
On the market
VENISTAR 3-VENI0030N
STARMED CO., LTD
3-VENI0030N08809306767868
Single use: yes
On the market
VENISTAR 7-VENI007090N
STARMED CO., LTD
7-VENI007090N08809306764010
Single use: yes
On the market
VENISTAR 7-VENI0070N
STARMED CO., LTD
7-VENI0070N08809306767875
Single use: yes
On the market
VVR Generator VVR10
STARMED CO., LTD
VVR1008809306769244
Single use: no
On the market

Similar devices in this category

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

Other devices from Starmed Co., Ltd

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Properties

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