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Owl Urf-3AP

by Diros Technology, Inc.

Ref 653-100Model URF-3AP(ML)

Owl Urf-3AP (653-100) is a device classified as Class IIb in the EU and Class II in the US made by Diros Technology, Inc., registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 0825114GN3APMLF8), cleared under FDA 510(k) K093185 on 22 Jan 2010 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 00825114000018), 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) K093185

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 Number0825114GN3APMLF8 Basic UDI-DI 00825114000018UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00825114000018 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK093185 Date22 Jan 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0825114GN3APMLF8 registered 23 Jun 2026 Active
  • FDA 510(k) K093185 decided 22 Jan 2010 Active
  • FDA GUDID UDI-DI 00825114000018 listed 1 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K093185
  2. Listed FDA GUDID 00825114000018
  3. Registered EUDAMED 0825114GN3APMLF8

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  • Withdrawn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
Owl
Generic name
Percutaneous radio-frequency ablation system generator
Device name
OWL Universal RF System
Model / Ref / Catalog
URF-3AP(ML), 653-100, URF-3AP
Primary DI / UDI-DI
00825114000018
Basic UDI-DI
0825114GN3APMLF8
Direct marketing DI
00825114000018
510(k) Number
FDA product code
GXD
EMDN code
Z121001 Radiofrequency nervous tissue ablation instruments
GMDN term
Percutaneous radio-frequency ablation system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.4400
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
URF-3AP(ML)
653-100
GUDID
URF-3AP
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 (K093185)

Similar devices in this category

Other devices filed under NEUROLOGY AND NEUROSURGERY INSTRUMENTS.

Other devices from Diros Technology, Inc.

See all devices from Diros Technology, Inc. →

Properties

  • Serial number
Other properties (24, all answered No)