Cleared Traditional

K093227 - SILVERSTREAM AND DERMASEPT

K093227 · Enzysurge , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
57d
Days
-
Risk

K093227 is an FDA 510(k) clearance for the SILVERSTREAM AND DERMASEPT. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Enzysurge , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on December 10, 2009 after a review of 57 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 - K093227

510(k) Number K093227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2009
Decision Date December 10, 2009
Days to Decision 57 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
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 709
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K093227 · SILVERSTREAM AND DERMASEPT
Download PDF FDA Summary Enzysurge , Ltd.