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Conmed IM8000

by Conmed Corporation

Conmed IM8000 is a Class II device made by Conmed Corporation, cleared under FDA 510(k) K161017 on 9 May 2016 and listed in FDA GUDID since 24 Mar 2026 (UDI-DI 10845854080603), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

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) K161017

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 Number10845854080603 UDI-DI Date24 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK161017 Date9 May 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161017 decided 9 May 2016 Active
  • FDA GUDID UDI-DI 10845854080603 listed 24 Mar 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161017
  2. Listed FDA GUDID 10845854080603

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Conmed
Generic name
Endoscopic video image processing unit
Model / Ref / Catalog
IM8000
Primary DI / UDI-DI
10845854080603
510(k) Number
FDA product code
GCJ
GMDN term
Endoscopic video image processing unit
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)