Cleared Traditional

K883887 - AXIOM ATRAUM WOUND DRAINS

K883887 is an FDA 510(k) clearance for AXIOM ATRAUM WOUND DRAINS, manufactured by Axiom, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBS cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K883887 · Axiom, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
157d
Days
Class 1
Risk

K883887 is an FDA 510(k) clearance for the AXIOM ATRAUM WOUND DRAINS. Classified as Catheter, Ventricular, General & Plastic Surgery (product code GBS), Class I - General Controls.

Submitted by Axiom, Inc. (Paramount, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 157 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Axiom, Inc. devices

FDA 510(k) Submission Details - K883887

510(k) Number K883887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1988
Decision Date February 17, 1989
Days to Decision 157 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 115d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

GBS Device Classification - Class 1, General Controls

Product Code GBS Catheter, Ventricular, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBS Catheter, Ventricular, General & Plastic Surgery

All 20
Devices cleared under the same product code (GBS) and FDA review panel - the closest regulatory comparables to K883887.
ATRIUMS PDR THORACIC CATHETER
K912645 · Atrium Medical Corp. · Sep 1991
INTRODUCTION/DRAINAGE CATHETER & ACCESS
K881873 · Sheridan Catheter Corp. · May 1988
URESIL WOUND DRAIN TROCAR
K880895 · Uresil Corp. · Mar 1988
NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP
K880376 · Genesis Industries, Inc. · Feb 1988
CLOSED CHEST DRAINAGE SET W/SUTURES
K873377 · Gish Biomedical, Inc. · Oct 1987
URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA
K863560 · Uresil Corp. · Sep 1986