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Core Dynamics CD4011P

by Conmed Corporation

Core Dynamics CD4011P is a Class II device made by Conmed Corporation, cleared under FDA 510(k) K950457 on 5 May 1995 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 20653405045684), 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) K950457

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 Number20653405045684 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK950457 Date5 May 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K950457 decided 5 May 1995 Active
  • FDA GUDID UDI-DI 20653405045684 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K950457
  2. Listed FDA GUDID 20653405045684

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  • Withdrawn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 trocar blade, single-use
Model / Ref / Catalog
CD4011P
Primary DI / UDI-DI
20653405045684
510(k) Number
FDA product code
HET
GMDN term
Laparoscopic trocar blade, single-use
Device class
Class II
Regulation number
884.1720
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide
Size
Outer Diameter — 10 Millimeter
Length — 110 Meter

Related devices

Category: Laparoscopic trocar blade, single-use

Cleared under the same submission (K950457)

and 2 more cleared under K950457

Similar devices

Other devices filed under FDA product code HET (LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)).

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)