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Examine PCC01

by Conmed Corporation

Ref PCC01

Examine PCC01 is an ERCP catheter (EU MDD Class IIa; FDA Class II; FDA product code GEI, Electrosurgical, cutting & coagulation & accessories) made by Conmed Corporation, registered in EUDAMED on 16 Jun 2026 (Basic UDI-DI B-10653405037569), cleared under FDA 510(k) K921921 on 17 Aug 1992 and listed in FDA GUDID since 4 Dec 2023 (UDI-DI 10653405037569), 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) K921921

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-10653405037569 Basic UDI-DI 10653405037569UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10653405037569 UDI-DI Date4 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK921921 Date17 Aug 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10653405037569 registered 16 Jun 2026 Active
  • FDA 510(k) K921921 decided 17 Aug 1992 Active
  • FDA GUDID UDI-DI 10653405037569 listed 4 Dec 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K921921
  2. Listed FDA GUDID 10653405037569
  3. Registered EUDAMED B-10653405037569

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  • Withdrawn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
Examine
Generic name
ERCP catheter, non-balloon, non-electrical, single-use
Device name
Surgical Instruments and Accessories
Model / Ref / Catalog
PCC01
Primary DI / UDI-DI
10653405037569
Basic UDI-DI
B-10653405037569
510(k) Number
FDA product code
GEI
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
ERCP catheter, non-balloon, non-electrical, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Category: ERCP catheter, non-balloon, non-electrical, single-use

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)