Cleared Traditional

K090100 - SOFTSEAL-STF

K090100 · Chitogen, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
55d
Days
-
Risk

K090100 is an FDA 510(k) clearance for the SOFTSEAL-STF. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Chitogen, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 11, 2009 after a review of 55 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 - K090100

510(k) Number K090100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2009
Decision Date March 11, 2009
Days to Decision 55 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

QSY Device Classification - Class 0,

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 126
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K090100 · SOFTSEAL-STF
Download PDF FDA Summary Chitogen, Inc.