Mediflex Injection Cap

FDA 510(k) K855039 · Mediflex Intl.

Substantially Equivalent

510(k) numberK855039

Submission

Device name
Mediflex Injection Cap
Applicant
Mediflex Intl.
Pine Brook, NJ, US
Received
December 17, 1985
Decision date
January 24, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GCE – Adaptor, Catheter
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Specialty
General, Plastic Surgery

Other 510(k)s with product code GCE

510(k)DeviceApplicantDecision
K901716Klein Connector(Tm)GCE · Traditional Jeff Klein Surgical, Inc.05/11/1990SE
K901715Klein Cork(Tm)GCE · Traditional Jeff Klein Surgical, Inc.05/11/1990SE
K801680Beta-Cap II AdapterGCE · Traditional Quinton, Inc.08/04/1980SE

More from Quinton, Inc.

510(k)DeviceDecision
K915140Primary Dressing TrayLYY · Traditional 02/11/1992SEKD
K900841Hemodialysis Transducer ProtectorFIB · Traditional 05/15/1990SE
K891077Mediverse Parenteral Nutrition BagKPE · Traditional 05/24/1989SE
K884243Blood Tubing SetFJK · Traditional 12/08/1988SE
K863496Mediflex Transducer ProtectorFIB · Traditional 09/23/1986SE
K854346Mediflex Disposable Tubing ClampFPA · Traditional 11/18/1985SE
K852106I.V. Administration SetFPA · Traditional 06/07/1985SE
K843126Mediflex Drainage BagKNX · Traditional 10/04/1984SE

Questions and answers

When was Mediflex Injection Cap cleared by the FDA?

Mediflex Injection Cap (K855039) received a 510(k) decision of Substantially Equivalent on January 24, 1986, 38 days after the submission was received.

What is the product code of K855039?

The FDA product code is GCE – Adaptor, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.