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Abc D-Flex 60-8627-001

by Conmed Corporation

Ref 60-8627-001

Abc D-Flex 60-8627-001 is an inert gas-enhanced electrosurgical system (EU MDD Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, cutting & coagulation & accessories) made by Conmed Corporation, registered in EUDAMED on 19 Jun 2026 (Basic UDI-DI B-10653405082507), cleared under FDA 510(k) K151229 on 2 Jun 2016 and listed in FDA GUDID since 15 Oct 2021 (UDI-DI 10653405082507), withdrawn (EUDAMED), active (FDA 510(k)) as of 23 Oct 2026.

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US).

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is 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) K151229

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-10653405082507 Basic UDI-DI 10653405082507UDI-DIDate19 Jun 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number10653405082507 UDI-DI Date15 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK151229 Date2 Jun 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10653405082507 registered 19 Jun 2026 Withdrawn
  • FDA 510(k) K151229 decided 2 Jun 2016 Active
  • FDA GUDID UDI-DI 10653405082507 listed 15 Oct 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151229
  2. Listed FDA GUDID 10653405082507
  3. Registered EUDAMED B-10653405082507

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Abc D-Flex
Generic name
Inert gas-enhanced electrosurgical system
Device name
Electrosurgical accessories
Model / Ref / Catalog
60-8627-001
Primary DI / UDI-DI
10653405082507
Basic UDI-DI
B-10653405082507
510(k) Number
FDA product code
GEI
EMDN code
Z129099 Various instruments for functional exploration and therapeutic interventions - other
GMDN term
Inert gas-enhanced electrosurgical system
Device class
Class IIb 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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb 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: Inert gas-enhanced electrosurgical system

Similar devices

Also classified as Inert gas-enhanced electrosurgical system.

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

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