Cleared Traditional

K896176 - EXUSORB(TM) DRY/WET DRESSING

K896176 is an FDA 510(k) clearance for EXUSORB(TM) DRY/WET DRESSING, manufactured by Controlled Therapeutics Corp.. The device is a Class 1 General & Plastic Surgery device with product code KOZ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K896176 · Controlled Therapeutics Corp. · General & Plastic Surgery device
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Nov 1989
Decision
30d
Days
Class 1
Risk

K896176 is an FDA 510(k) clearance for the EXUSORB(TM) DRY/WET DRESSING. Classified as Beads, Hydrophilic, For Wound Exudate Absorption (product code KOZ), Class I - General Controls.

Submitted by Controlled Therapeutics Corp. (Malvern, US). The FDA issued a Cleared decision on November 24, 1989 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4018 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Controlled Therapeutics Corp. devices

FDA 510(k) Submission Details - K896176

510(k) Number K896176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1989
Decision Date November 24, 1989
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

KOZ Device Classification - Class 1, General Controls

Product Code KOZ Beads, Hydrophilic, For Wound Exudate Absorption
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4018
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 - KOZ Beads, Hydrophilic, For Wound Exudate Absorption

All 12
Devices cleared under the same product code (KOZ) and FDA review panel - the closest regulatory comparables to K896176.
DERMASORB WOUND CONTACT LAYER DRESSING
K903645 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990
ALLEVYN DRESSING CLAIMS CHANGE
K904412 · Smith & Nephew United, Inc. · Oct 1990
INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)
K901876 · Smith & Nephew United, Inc. · Jun 1990
INTRASITE CAVITY WOUND DRESSING
K895354 · Smith & Nephew United, Inc. · Nov 1989
ENVISAN PAD
K874552 · Marion Laboratories, Inc. · Jan 1988
DEBRISAN ABSORBENT PAD
K872453 · Pharmacia, Inc. · Jan 1988