Cleared Traditional

K090620 - QUIKCLOT INTEVENTIONAL, MODEL P/N 182

K090620 · Z-Medica Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
30d
Days
-
Risk

K090620 is an FDA 510(k) clearance for the QUIKCLOT INTEVENTIONAL, MODEL P/N 182. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Z-Medica Corporation (Wallingford, US). The FDA issued a Cleared decision on April 8, 2009 after a review of 30 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 - K090620

510(k) Number K090620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2009
Decision Date April 08, 2009
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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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K090620 · QUIKCLOT INTEVENTIONAL, MODEL P/N 182
Download PDF FDA Summary Z-Medica Corporation