Cleared Traditional

K896702 - WOUND DRESSING

K896702 · Viaderm Pharmaceuticals, Inc. · General & Plastic Surgery device
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Jan 1990
Decision
52d
Days
-
Risk

K896702 is an FDA 510(k) clearance for the WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Viaderm Pharmaceuticals, Inc. (Rancho Santa Fe, US). The FDA issued a Cleared decision on January 19, 1990 after a review of 52 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Viaderm Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K896702

510(k) Number K896702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1989
Decision Date January 19, 1990
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 598
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K896702.
INCARE HOT/ICE ABSORBENT INTERFACE
K913035 · Hollister, Inc. · Sep 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons · Jan 1991
WOUND TREATMENT KIT
K901109 · Orion Life Systems, Inc. · Jun 1990
SILASTIC SOFT SHEETING
K894226 · Dow Corning Wright · Jan 1990
KALTOCARB WOUND DRESSING
K894347 · Calgon Vestal Div. · Aug 1989
INTRASITE* GEL (3) YEAR SHELF LIFE
K891870 · Smith & Nephew United, Inc. · Aug 1989