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Penadapt PA2010

by Conmed Corporation

Ref PA2010

Penadapt PA2010 is a device classified as Class IIa in the EU and Class II in the US made by Conmed Corporation, registered in EUDAMED on 27 May 2026 (Basic UDI-DI B-20845854080778), cleared under FDA 510(k) K230547 on 27 Apr 2023 and listed in FDA GUDID since 1 Jun 2020 (UDI-DI 20845854080778), 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) K230547

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-20845854080778 Basic UDI-DI 20845854080778UDI-DIDate27 May 2026RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK230547 Date27 Apr 2023IssuedStatusActive
United StatesGUDID listing GUDID Number20845854080778 UDI-DI Date1 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-20845854080778 registered 27 May 2026 Active
  • FDA 510(k) K230547 decided 27 Apr 2023 Active
  • FDA GUDID UDI-DI 20845854080778 listed 1 Jun 2020 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 20845854080778
  2. Cleared FDA 510(k) K230547
  3. Registered EUDAMED B-20845854080778

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  • Withdrawn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
Penadapt
Generic name
Surgical plume evacuation system tube
Device name
Electrosurgical Accessories
Model / Ref / Catalog
PA2010
Primary DI / UDI-DI
20845854080778
Basic UDI-DI
B-20845854080778
510(k) Number
FDA product code
FYD
EMDN code
K02010107 Smoke evacuation systems
GMDN term
Surgical plume evacuation system tube
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.5070
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
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 20845854080778: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa 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

Cleared under the same submission (K230547)

Similar devices in this category

Other devices filed under SMOKE EVACUATION SYSTEMS.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)