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Polaris

by Kirwan Surgical Products LLC 39 variants

Ref 22-1642PL

Polaris (22-1642PL) is a device classified as Class IIb in the EU and Class II in the US made by Kirwan Surgical Products LLC, registered in EUDAMED on 26 Sep 2025 (Basic UDI-DI B-00841019123041), cleared under FDA 510(k) K811820 on 28 Jul 1981 and listed in FDA GUDID since 30 Sep 2025 (UDI-DI 00841019123041), 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) K811820

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00841019123041 UDI-DI Date30 Sep 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-00841019123041 Basic UDI-DI 00841019123041UDI-DIDate26 Sep 2025RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK811820 Date28 Jul 1981DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00841019123041 registered 26 Sep 2025 Active
  • FDA 510(k) K811820 decided 28 Jul 1981 Active
  • FDA GUDID UDI-DI 00841019123041 listed 30 Sep 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K811820
  2. Registered EUDAMED B-00841019123041
  3. Listed FDA GUDID 00841019123041

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  • Withdrawn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
Polaris EUDAMED
Kirwan GUDID
Generic name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Device name
Reusable Bipolar Forceps, 8in. (20.3cm), 0.5mm Tip, Non-Stick, Bayonet, Irrigating, Insulated
Model / reference
22-1642PL
Primary DI / UDI-DI
00841019123041
Basic UDI-DI
B-00841019123041
510(k) Number
FDA product code
GEI
EMDN code
L180401 Open electrosurgery forceps, reusable
GMDN term
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
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
Sterilisation method
Moist Heat or Steam Sterilization

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.

Manufacturer details

EUDAMED SRN
US-MF-000008222
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Related devices

Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

Similar devices in this category

Other devices filed under OPEN ELECTROSURGERY FORCEPS, REUSABLE.

Other devices from Kirwan Surgical Products LLC

See all devices from Kirwan Surgical Products LLC →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)