AXIOM HYDROMER WOUND DRAINS— 510(k) K832416

Name: FDA 510(k) clearance K832416
Creator: U.S. Food and Drug Administration
Published: 1983-10-31

Substantially Equivalent

Axiom Medical, Inc.

FDA 510(k) clearance K832416 for AXIOM HYDROMER WOUND DRAINS, Substantially Equivalent on 1983-10-31. Applicant: Axiom Medical, Inc.. Device class: 1.

Clearance details

Applicant: Axiom Medical, Inc.
Product code: Code GBS
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1983-07-21
Decision date: 1983-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GBS

view all

K912645 — ATRIUMS PDR THORACIC CATHETER1991-09-13
K883887 — AXIOM ATRAUM WOUND DRAINS1989-02-17
K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESS1988-05-18
K880895 — URESIL WOUND DRAIN TROCAR1988-03-14
K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP1988-02-16

More clearances from Axiom Medical, Inc.

view all

K993592 — AXIOM MULTIPURPOSE WOUND DRAIN2000-05-17
K971851 — INTERPLEURAL ANESTHESIA CATHETER1998-01-22
K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR1997-03-10
K934895 — GLASSMAN SILICONE CATHETER1994-10-13
K922760 — ATRAUM WOUND DRESSING--MODIFICATION1992-10-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.