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Eliminator

by Conmed Corporation United States EUDAMEDGUDID

Ref 000848, 000861, 000343, 000844, 000345, 000380, 000341, 000344, 000849

Product code KNQEMDN G0301010302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084585408513D6 Basic UDI-DIDate28 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number20653405052569 UDI-DIDate24 Sep 2016ListedStatusIn 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
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

13 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-0939-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007
    • Terminated Z-0938-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007
    • Terminated Z-0937-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007
    • Terminated Z-0942-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007
    • Terminated Z-0941-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007
    • Terminated Z-0945-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007
    • Terminated Z-0946-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007
    • Terminated Z-0949-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007
    • Terminated Z-0940-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007
    • Terminated Z-0948-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007
    • Terminated Z-0947-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007
    • Terminated Z-0943-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007

    Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.

    • Terminated Z-0944-2007 FDA Unclassified (pre-2012) initiated 16 Apr 2007

    Complaints received regarding PET Balloon Dilators for a variety of labeling errors, including: incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Gastrointestinal/biliary dilation balloon catheter, non-medicated
Device Name
Non-orthopedic, Non-active, Instrument, Endoscopic, Dilator
Model / Ref / Catalog
000848, 000861, 000343, 000844, 000345, 000380, 000341, 000344, 000849
Primary DI / UDI-DI
20653405052569, 20653405052583, 20653405052446, 20653405052521, 20653405052460, 20653405052477, 20653405052422, 20653405052453, 20653405052576
Basic UDI-DI
084585408513D6
510(k) Number
FDA Product Code
KNQ
EMDN Code
G0301010302, G0301010102
GMDN Term
Gastrointestinal/biliary dilation balloon catheter, non-medicated
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5365
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
Size
Pressure — 4100 millibar
Outer Diameter — 15 Centimeter
Pressure — 60 Pound per Square Inch
Catheter Gauge — 45 French
Length — 8 Millimeter
Pressure — 3400 millibar
Catheter Gauge — 54 French
Pressure — 50 Pound per Square Inch
Outer Diameter — 18 Centimeter
Outer Diameter — 20 Centimeter
Catheter Gauge — 60 French
Pressure — 120 Pound per Square Inch
Catheter Gauge — 24 French
Outer Diameter — 8 Centimeter
Pressure — 8300 millibar
Pressure — 90 Pound per Square Inch
Outer Diameter — 12 Centimeter
Catheter Gauge — 36 French
Pressure — 6200 millibar

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
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
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (20)
  • Sterile: No
  • 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 (18)

  • EUDAMED 0a4f9bfd-f468-4408-8ba2-5f5b450906e2 61 fields · synced 22 Oct 2026
  • EUDAMED 20653405052583|084585408513D6 61 fields · synced 16 May 2026
  • EUDAMED 20653405052446|084585408513D6 61 fields · synced 18 May 2026
  • EUDAMED 20653405052521|084585408513D6 61 fields · synced 18 May 2026
  • EUDAMED 20653405052460|084585408513D6 61 fields · synced 18 May 2026
  • EUDAMED 20653405052477|084585408513D6 61 fields · synced 18 May 2026
  • EUDAMED 20653405052422|084585408513D6 61 fields · synced 18 May 2026
  • EUDAMED 20653405052453|084585408513D6 61 fields · synced 18 May 2026
  • EUDAMED 20653405052576|084585408513D6 61 fields · synced 18 May 2026
  • FDA UDI 4f9e1442-9593-4e07-830d-f26b574b9da3 37 fields · synced 27 May 2026
  • FDA UDI 6a20153d-def8-4779-81ce-370e28459a67 37 fields · synced 30 May 2026
  • FDA UDI 723339a4-766a-4c34-9b65-38e7194f7ee6 37 fields · synced 30 May 2026
  • FDA UDI 7e5e0995-9971-44a3-8158-72b5cb887f4f 37 fields · synced 30 May 2026
  • FDA UDI 90616b25-2c43-4868-885e-958c522bfaa5 37 fields · synced 30 May 2026
  • FDA UDI f7c65941-9918-468f-9add-3c176818caa3 37 fields · synced 30 May 2026
  • FDA UDI 00a964d0-7366-4108-9481-4cf9aee80567 37 fields · synced 30 May 2026
  • FDA UDI f400a556-3906-4e2f-840c-a7f65d4aa3bf 37 fields · synced 30 May 2026
  • FDA UDI 76fbd4bc-5bc8-4d2a-a97b-0f0145d8547b 37 fields · synced 30 May 2026