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PlumePen

by Conmed Corporation United States EUDAMED510(k)GUDID

Ref PLP1020, PLP2520, PLPUL2020, PLPRO4020, PROTIP420, PROTIP620510(k) K230547

Product code GEIEMDN K02030109

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10845854061268 Basic UDI-DIDate11 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK230547 Date27 Apr 2023ClearedStatusActive
United StatesGUDID listing GUDID Number10845854061268 UDI-DIDate5 Jun 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring (legacy directive)
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Expiring (legacy directive)

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Surgical plume evacuation system tube
Device Name
Non-orthopedic, Active, Instrument, Electrosurgical, Pencil, Smoke Evacuation
Electrosurgical Accessories
Model / Ref / Catalog
PLP1020, PLP2520, PLPUL2020, PROTIP620, PROTIP420, PLPRO4020
Primary DI / UDI-DI
10845854061268, 10845854061305, 20845854061210, 20845854061333, 20845854061319, 20845854061197
Basic UDI-DI
B-10845854061268, B-10845854061305, B-20845854061210, B-20845854061197, B-20845854061319, B-20845854061333
510(k) Number
FDA Product Code
GEI
EMDN Code
K02030109, K02010107
GMDN Term
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Surgical plume evacuation system tube
Device Class
Class IIb EUDAMED
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 878.4400
Market of Registration
Belgium
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Outer Diameter — 22 Millimeter
Outer Diameter — 0.875 Inch
Length — 3 Meter
Length — 10 Feet
Length — 15 Feet
Length — 4.6 Meter

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
510(k) NumberEUDAMED
n/a
510(k)
K230547
GUDID
K103375
Device ClassEUDAMED
Class IIb
Class IIa
510(k)
Class II
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (19)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (13)

  • EUDAMED 988cdcea-7eea-489b-bd37-8f7e513abc58 61 fields · synced 24 Oct 2026
  • EUDAMED 10845854061305|B-10845854061305 61 fields · synced 18 May 2026
  • EUDAMED 20845854061210|B-20845854061210 61 fields · synced 18 May 2026
  • FDA 510(k) K230547 24 fields · synced 18 May 2026
  • FDA UDI b48b5575-b046-4ab8-991f-cd98ea87a473 37 fields · synced 30 May 2026
  • FDA UDI c71aa0a5-0d53-4c28-b9c3-b706d32b3306 37 fields · synced 30 May 2026
  • FDA UDI bf211227-34ad-43e3-a74c-09c9bdeba67f 37 fields · synced 30 May 2026
  • FDA UDI 4770c3b6-2476-4dc7-bb15-6b95449ea1c7 37 fields · synced 30 May 2026
  • FDA UDI 68368885-ec31-4679-a6a7-05bc35a42449 37 fields · synced 30 May 2026
  • FDA UDI ea522d68-3254-4985-b2db-088f2fe54779 37 fields · synced 30 May 2026
  • EUDAMED 20845854061197|B-20845854061197 61 fields · synced 14 Jul 2026
  • EUDAMED 20845854061319|B-20845854061319 61 fields · synced 18 Jul 2026
  • EUDAMED 20845854061333|B-20845854061333 61 fields · synced 24 Jul 2026