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Abc D-Flex 60-8727-001

by Conmed Corporation

Abc D-Flex 60-8727-001, an inert gas-enhanced electrosurgical system (FDA Class II; FDA product code GEI, Electrosurgical, cutting & coagulation & accessories) made by Conmed Corporation, was cleared under FDA 510(k) K151229 on 2 Jun 2016 and listed in FDA GUDID on 15 Oct 2021 (UDI-DI 10653405082491); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K151229

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10653405082491 UDI-DI Date15 Oct 2021ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151229 Date2 Jun 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151229 decided 2 Jun 2016 Active
  • FDA GUDID UDI-DI 10653405082491 listed 15 Oct 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151229
  2. Listed FDA GUDID 10653405082491

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Abc D-Flex
Generic name
Inert gas-enhanced electrosurgical system
Model / Ref / Catalog
60-8727-001
Primary DI / UDI-DI
10653405082491
510(k) Number
FDA product code
GEI
GMDN term
Inert gas-enhanced electrosurgical system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K151229)

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, cutting & coagulation & accessories).

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 (10, all answered No)