Axiom Atraum Wound Drains

FDA 510(k) K883887 · Axiom, Inc.

Substantially Equivalent

510(k) numberK883887

Submission

Device name
Axiom Atraum Wound Drains
Applicant
Axiom, Inc.
Paramount, CA, US
Received
September 13, 1988
Decision date
February 17, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code GBS

510(k)DeviceApplicantDecision
K912645Atriums PDR Thoracic CatheterGBS · Traditional Atrium Medical Corp.09/13/1991SE
K881873Introduction/Drainage Catheter & AccessGBS · Traditional Sheridan Catheter Corp.05/18/1988SE
K880895Uresil Wound Drain TrocarGBS · Traditional Uresil Corp.03/14/1988SE
K880376Novo Vivo Suction Catheter Vessel W/Mucose TrapGBS · Traditional Genesis Industries, Inc.02/16/1988SE
K873377Closed Chest Drainage Set W/SuturesGBS · Traditional Gish Biomedical, Inc.10/28/1987SE
K872460AN3000 Mahoney DrainGBS · Traditional H.W. Andersen Products, Inc.07/23/1987SE
K872459AN3100 Mulholland DrainGBS · Traditional H.W. Andersen Products, Inc.07/21/1987SE
K872457AN3500 Worth DrainGBS · Traditional H.W. Andersen Products, Inc.07/21/1987SE
K870015Hci All Purpose Drain/Catheter SetGBS · Traditional Health Care Innovations, Inc.02/06/1987SE
K863560Uresil STD Flat/Round & Flat/Round Split. Sili/DraGBS · Traditional Uresil Corp.09/29/1986SE

More from Uresil Corp.

510(k)DeviceDecision
K842443Axiom Stable II Triglycerides TestCDT · Traditional 09/13/1984SE
K842442Axiom Stable II Uric Acid TestKNK · Traditional 08/16/1984SE
K842441Axiom Stable II Cholesterol TestCHH · Traditional 07/25/1984SE

Questions and answers

When was Axiom Atraum Wound Drains cleared by the FDA?

Axiom Atraum Wound Drains (K883887) received a 510(k) decision of Substantially Equivalent on February 17, 1989, 157 days after the submission was received.

What is the product code of K883887?

The FDA product code is GBS – Catheter, Ventricular, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4200.