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ClosureRFG™ RFG3

by Medtronic, Inc.

Ref RFG3

ClosureRFG™ RFG3 is a device classified as Class IIb in the EU and Class II in the US made by Medtronic, Inc., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 0763000B00004077G), cleared under FDA 510(k) K141858 on 5 Aug 2014 and listed in FDA GUDID since 10 Aug 2019 (UDI-DI 00763000723316), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K141858

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00004077G Basic UDI-DI 00763000723316UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000723316 UDI-DI Date10 Aug 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK141858 Date5 Aug 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00004077G registered 21 May 2026 Active
  • FDA 510(k) K141858 decided 5 Aug 2014 Active
  • FDA GUDID UDI-DI 00763000723316 listed 10 Aug 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K141858
  2. Listed FDA GUDID 00763000723316
  3. Registered EUDAMED 0763000B00004077G

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  • Withdrawn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

Trade name
ClosureRFG™
Generic name
Percutaneous radio-frequency ablation system generator
Device name
ClosureRFG Generator
Model / reference
RFG3
Primary DI / UDI-DI
00763000723316, 10884521777545
Basic UDI-DI
0763000B00004077G
510(k) Number
FDA product code
GEI
EMDN code
K020399 Devices for surgery with radiofrequency generator, single-use - other
GMDN term
Percutaneous radio-frequency ablation system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
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 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: Percutaneous radio-frequency ablation system generator

Cleared under the same submission (K141858)

Similar devices in this category

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

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)