Cleared Traditional

K080010 - NOCC HYDROPHILIC WOUND DRESSING

K080010 · Kytogenics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
71d
Days
-
Risk

K080010 is an FDA 510(k) clearance for the NOCC HYDROPHILIC WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Kytogenics, Inc. (Chatham, US). The FDA issued a Cleared decision on March 14, 2008 after a review of 71 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.

FDA 510(k) Submission Details - K080010

510(k) Number K080010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2008
Decision Date March 14, 2008
Days to Decision 71 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 188
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K080010.
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UNITE BIOMATRIX
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MODIFICATION TO COLLAWOUND DRESSING
K070269 · Collamatrix Co., Inc. · Mar 2007
K080010 · NOCC HYDROPHILIC WOUND DRESSING
Download PDF FDA Summary Kytogenics, Inc.