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Core Dynamics CD801

by Conmed Corporation

Core Dynamics CD801 is a Class II device made by Conmed Corporation, cleared under FDA 510(k) K955490 on 22 Jan 1996 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 20653405043277), 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) K955490

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 Number20653405043277 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK955490 Date22 Jan 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K955490 decided 22 Jan 1996 Active
  • FDA GUDID UDI-DI 20653405043277 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K955490
  2. Listed FDA GUDID 20653405043277

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Core Dynamics
Generic name
Laparoscopic blunt dissector
Model / Ref / Catalog
CD801
Primary DI / UDI-DI
20653405043277
510(k) Number
FDA product code
GCJ
GMDN term
Laparoscopic blunt dissector
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide
Size
Outer Diameter — 5 Millimeter
Length — 40 Centimeter

Related devices

Category: Laparoscopic blunt dissector

Cleared under the same submission (K955490)

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, general & plastic surgery).

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)