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Venclose Power Cord

by Venclose, Inc. 6 variants

Ref VC-PC-E

Venclose Power Cord (VC-PC-E) is an electrical mains power cable (EU MDR Class I; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Venclose Inc, registered in EUDAMED on 12 Nov 2022 (Basic UDI-DI 0858254006VCPCE6G), cleared under FDA 510(k) K160754 on 9 Sep 2016 and listed in FDA GUDID since 1 Nov 2016 (UDI-DI 00858254006053), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

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

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160754

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 Number0858254006VCPCE6G Basic UDI-DI 00858254006053UDI-DIDate12 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00858254006053 UDI-DI Date1 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160754 Date9 Sep 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0858254006VCPCE6G registered 12 Nov 2022 Active
  • FDA 510(k) K160754 decided 9 Sep 2016 Active
  • FDA GUDID UDI-DI 00858254006053 listed 1 Nov 2016 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2638-2025 FDA Class II initiated 21 Aug 2025

    Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.

    • Ongoing Z-0371-2025 FDA Class II initiated 4 Sep 2024

    The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature.

Timeline

5 dated events

  1. Cleared FDA 510(k) K160754
  2. Listed FDA GUDID 00858254006053
  3. Registered EUDAMED 0858254006VCPCE6G
  4. Recall initiated FDA recalls Z-0371-2025
  5. Recall initiated FDA recalls Z-2638-2025

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
Venclose Power Cord EUDAMED
Venclose System Power Cord GUDID
Generic name
Electrical mains power cable
Model / reference
VC-PC-E EUDAMED
VCPCE GUDID
Primary DI / UDI-DI
00858254006053
Basic UDI-DI
0858254006VCPCE6G
510(k) Number
FDA product code
GEI
EMDN code
Z12010980 Electrosurgery instruments - hardware accessories
GMDN term
Electrical mains power cable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
VC-PC-E
GUDID
VCPCE
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000001372
Authorised representative
ICON (LR) Limited IE-AR-000006507

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Venclose Inc

See all devices from Venclose Inc →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)