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Endura

by Conmed Corporation

Ref C9014, C9143, C9032, C9031, C9013, C9145, C9144

Endura (C9014) is a device classified as Class IIa in the EU and Class II in the US made by Conmed Corporation, registered in EUDAMED on 8 Apr 2026 (Basic UDI-DI B-20845854020330), cleared under FDA 510(k) K943985 on 7 Nov 1994 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 20845854020330), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K943985

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-20845854020330 Basic UDI-DI Date8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20845854020330 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK943985 Date7 Nov 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-20845854020330 registered 8 Apr 2026 Active
  • FDA 510(k) K943985 decided 7 Nov 1994 Active
  • FDA GUDID UDI-DI 20845854020330 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K943985
  2. Listed FDA GUDID 20845854020330
  3. Registered EUDAMED B-20845854020330

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  • Withdrawn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
Endura
Endura Vortex
Generic name
Orthopaedic bur, reusable
Arthroscopic shaver system blade, reusable
Device name
Orthopedic, Non-active, Shaver Blade/Bur, Endura
Model / Ref / Catalog
C9014, C9143, C9032, C9031, C9013, C9145, C9144
Primary DI / UDI-DI
20845854020330, 20845854020385, 20845854020361, 20845854020354, 20845854020323, 20845854020408, 20845854020392
Basic UDI-DI
B-20845854020330, B-20845854020385, B-20845854020361, B-20845854020354, B-20845854020323, B-20845854020408, B-20845854020392
510(k) Number
FDA product code
HRX, HWE
EMDN code
L0916, L1999
GMDN term
Orthopaedic bur, reusable
Arthroscopic shaver system blade, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.1100, 878.4820
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization
Size
Outer Diameter — 3.5 Millimeter
Outer Diameter — 4.5 Millimeter
Outer Diameter — 5.5 Millimeter
Outer Diameter — 4.2 Millimeter

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 20845854020330: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 20845854020385: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 20845854020361: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 20845854020354: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 20845854020323: 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.

Manufacturer details

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

Related devices

Category: Fluted surgical drill bit, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE.

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)