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Conmed 1412

by Conmed Corporation

Ref 1412

Conmed 1412 is an endoscopic electrosurgical handpiece/electrode (EU MDD Class IIb; FDA Class II; FDA product code KNF, Coagulator-Cutter, Endoscopic, Unipolar (and Accessories)) made by Conmed Corporation, registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI B-10653405035091), cleared under FDA 510(k) K924200 on 22 Feb 1994 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 10653405035091), 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) K924200

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-10653405035091 Basic UDI-DI 10653405035091UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10653405035091 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK924200 Date22 Feb 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10653405035091 registered 16 Jun 2026 Active
  • FDA 510(k) K924200 decided 22 Feb 1994 Active
  • FDA GUDID UDI-DI 10653405035091 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K924200
  2. Listed FDA GUDID 10653405035091
  3. Registered EUDAMED B-10653405035091

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  • Withdrawn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
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Device name
Surgical Instruments and Accessories
Model / Ref / Catalog
1412
Primary DI / UDI-DI
10653405035091
Basic UDI-DI
B-10653405035091
510(k) Number
FDA product code
KNF
EMDN code
K0299 Electrosurgery devices, single-use - other
GMDN term
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
884.4160
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

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: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Cleared under the same submission (K924200)

Similar devices in this category

Other devices filed under ELECTROSURGERY DEVICES, SINGLE-USE - OTHER.

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)