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Valleylab E0507B

by Covidien LP

Ref E0507-B

Valleylab E0507B is a device classified as Class I in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI 0763000B00009698X), cleared under FDA 510(k) K801153 on 20 May 1980 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10884521033788), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K801153

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00009698X Basic UDI-DI 10884521033788UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521033788 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK801153 Date20 May 1980DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00009698X registered 17 Sep 2026 Active
  • FDA 510(k) K801153 decided 20 May 1980 Active
  • FDA GUDID UDI-DI 10884521033788 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K801153
  2. Listed FDA GUDID 10884521033788
  3. Registered EUDAMED 0763000B00009698X

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  • Withdrawn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
ValleyabTM EUDAMED
Valleylab GUDID
Generic name
Electrosurgical cable adaptor
Model / reference
E0507-B EUDAMED
E0507B GUDID
Primary DI / UDI-DI
10884521033788
Basic UDI-DI
0763000B00009698X
Direct marketing DI
10884521033788
510(k) Number
FDA product code
GEI
EMDN code
L0317 General surgery adapters and connectors, reusable
GMDN term
Electrosurgical cable adaptor
Device class
Class I 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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
E0507-B
GUDID
E0507B
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.

Related devices

Category: Electrosurgical cable adaptor

Similar devices in this category

Other devices filed under GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE.

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Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)