Skip to content

Conmed 138113

by Conmed Corporation

Ref 138113

Conmed 138113 is a device classified as Class IIb in the EU and Class II in the US made by Conmed Corporation, registered in EUDAMED on 11 Apr 2026 (Basic UDI-DI B-30653405003476), cleared under FDA 510(k) K943542 on 1 Sep 1994 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 30653405003476), active as of 23 Oct 2026.

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

CE MDD 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) K943542

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/MDD EUDAMED NumberB-30653405003476 Basic UDI-DI 30653405003476UDI-DIDate11 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30653405003476 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK943542 Date1 Sep 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30653405003476 registered 11 Apr 2026 Active
  • FDA 510(k) K943542 decided 1 Sep 1994 Active
  • FDA GUDID UDI-DI 30653405003476 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K943542
  2. Listed FDA GUDID 30653405003476
  3. Registered EUDAMED B-30653405003476

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Conmed
Generic name
Open-surgery electrosurgical electrode, monopolar, single-use
Device name
Non-orthopedic, Active, Instrument, Electrosurgical, Electrode, Open, Uncoated, Disposable
Model / Ref / Catalog
138113
Primary DI / UDI-DI
30653405003476
Basic UDI-DI
B-30653405003476
510(k) Number
FDA product code
GEI
EMDN code
K02030101 Radiofrequency surgery electrodes, single-use
GMDN term
Open-surgery electrosurgical electrode, monopolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 3.5 Inch
Length — 8.9 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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: Open-surgery electrosurgical electrode, monopolar, single-use

Cleared under the same submission (K943542)

and 4 more cleared under K943542

Similar devices in this category

Other devices filed under RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)