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Kirwan 28-2600

by Kirwan Surgical Products LLC

Ref 28-2600

Kirwan 28-2600 is an electrosurgical system generator (EU MDD Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Kirwan Surgical Products LLC, registered in EUDAMED on 5 Nov 2021 (Basic UDI-DI B-00841019107027), cleared under FDA 510(k) K052203 on 20 Oct 2005 and listed in FDA GUDID since 8 Jun 2016 (UDI-DI 00841019107027), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K052203

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/MDD EUDAMED NumberB-00841019107027 Basic UDI-DI 00841019107027UDI-DIDate5 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number00841019107027 UDI-DI Date8 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK052203 Date20 Oct 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00841019107027 registered 5 Nov 2021 Active
  • FDA 510(k) K052203 decided 20 Oct 2005 Active
  • FDA GUDID UDI-DI 00841019107027 listed 8 Jun 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K052203
  2. Listed FDA GUDID 00841019107027
  3. Registered EUDAMED B-00841019107027

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  • Withdrawn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
Aura EUDAMED
Kirwan GUDID
Generic name
Electrosurgical system generator
Model / reference
28-2600
Primary DI / UDI-DI
00841019107027
Basic UDI-DI
B-00841019107027
510(k) Number
FDA product code
GEI
EMDN code
L1899 Electrosurgery instruments, reusable - other
GMDN term
Electrosurgical system generator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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: Electrosurgical system generator

Cleared under the same submission (K052203)

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Kirwan Surgical Products LLC

See all devices from Kirwan Surgical Products LLC →

Properties

  • Reusable
  • Prescription use
  • Serial number
Other properties (20, all answered No)