Cleared Traditional

K112215 - HEMCON HEMOSTATIC GEL

K112215 · Hemcon Medical Technologies Europe, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
254d
Days
-
Risk

K112215 is an FDA 510(k) clearance for the HEMCON HEMOSTATIC GEL. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hemcon Medical Technologies Europe, Ltd. (Portland, US). The FDA issued a Cleared decision on April 12, 2012 after a review of 254 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hemcon Medical Technologies Europe, Ltd. devices

FDA 510(k) Submission Details - K112215

510(k) Number K112215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2011
Decision Date April 12, 2012
Days to Decision 254 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
139d slower than avg
Panel avg: 115d · This submission: 254d
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 31
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K112215.
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CELSTAT
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