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PlasmaKinetic 744010

by Gyrus Acmi, Inc.

Ref 744010

PlasmaKinetic 744010 is an electrosurgical system (EU MDR Class I; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Gyrus Acmi, Inc., registered in EUDAMED on 31 Jul 2026 (Basic UDI-DI 0821925000085K), cleared under FDA 510(k) K031085 on 21 Jul 2003 and listed in FDA GUDID since 4 Oct 2016 (UDI-DI 00821925039599), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K031085

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 Number0821925000085K Basic UDI-DI 00821925039599UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925039599 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 0821925000085K registered 31 Jul 2026 Active
  • FDA 510(k) K031085 decided 21 Jul 2003 Active
  • FDA GUDID UDI-DI 00821925039599 listed 4 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K031085
  2. Listed FDA GUDID 00821925039599
  3. Registered EUDAMED 0821925000085K

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  • Withdrawn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
PlasmaKinetic
Generic name
Electrosurgical system
Device name
Gyrus, Pk-Sp Footswitch
Model / reference
744010
Primary DI / UDI-DI
00821925039599
Basic UDI-DI
0821925000085K
Direct marketing DI
00821925039599
510(k) Number
FDA product code
GEI
EMDN code
Z12010902 Electrosurgical units (esu) for general use
GMDN term
Electrosurgical system
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
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00821925039599: EUDAMED states No, FDA GUDID states Yes.

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 system

Cleared under the same submission (K031085)

and 3 more cleared under K031085

Similar devices in this category

Other devices filed under ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)