Cleared Traditional

K832416 - AXIOM HYDROMER WOUND DRAINS

K832416 is an FDA 510(k) clearance for AXIOM HYDROMER WOUND DRAINS, manufactured by Axiom Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBS cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K832416 · Axiom Medical, Inc. · General & Plastic Surgery device
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Oct 1983
Decision
102d
Days
Class 1
Risk

K832416 is an FDA 510(k) clearance for the AXIOM HYDROMER WOUND DRAINS. Classified as Catheter, Ventricular, General & Plastic Surgery (product code GBS), Class I - General Controls.

Submitted by Axiom Medical, Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 102 days - within the typical 510(k) review window.

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 Medical, Inc. devices

FDA 510(k) Submission Details - K832416

510(k) Number K832416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1983
Decision Date October 31, 1983
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
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 18
Devices cleared under the same product code (GBS) and FDA review panel - the closest regulatory comparables to K832416.
THORO/CATH STRAIGHT THORACIC RIGHT ANGLE
K853131 · J. H. Emerson Co. · Sep 1985
AXIOM ATRAUM TROCAR CATHETER
K852241 · Axiom Medical, Inc. · Jun 1985
CHEST CATHETERS/THORACIC CATHETERS
K851048 · Medovations, Inc. · Jun 1985
ARGYLE MEDIASTINAL DRAIN
K822318 · Sherwood Medical Co. · Aug 1982
SIL-V-UR CHEST CATHETER
K813463 · C.R. Bard, Inc. · Feb 1982
DISPOSABLE THORACIC CATHETER
K813587 · Texas Medical Products, Inc. · Jan 1982