Skip to content

PlasmaKinetic 714941

by Gyrus Acmi, Inc.

Ref 714941

PlasmaKinetic 714941 is an endoscopic electrosurgical handpiece/electrode (EU MDD Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Gyrus Acmi, Inc., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00821925009202), cleared under FDA 510(k) K031085 on 21 Jul 2003 and listed in FDA GUDID since 4 Oct 2016 (UDI-DI 00821925009202), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K031085

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00821925009202 Basic UDI-DI 00821925009202UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925009202 UDI-DI Date4 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK031085 Date21 Jul 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00821925009202 registered 6 Nov 2026 Active
  • FDA 510(k) K031085 decided 21 Jul 2003 Active
  • FDA GUDID UDI-DI 00821925009202 listed 4 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K031085
  2. Listed FDA GUDID 00821925009202
  3. Registered EUDAMED B-00821925009202

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  • Withdrawn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
PlasmaKinetic
Generic name
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Device name
714941
Model / reference
714941
Primary DI / UDI-DI
00821925009202 EUDAMED
00821925039551 GUDID
Basic UDI-DI
B-00821925009202
510(k) Number
FDA product code
GEI
EMDN code
K02010199 Mono- and bipolar instruments, single-use - other
GMDN term
Endoscopic electrosurgical handpiece/electrode, bipolar, 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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00821925009202
GUDID
00821925039551
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00821925009202; FDA GUDID lists 00821925039551), so their flags are not compared. 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, bipolar, single-use

Cleared under the same submission (K031085)

and 3 more cleared under K031085

Similar devices in this category

Other devices filed under MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)