Cleared Traditional

K072486 - MODIFICATION TO HEMCON BANDAGE AND HEMC...

K072486 · Hem Con Medical Technologies, Inc. · General & Plastic Surgery device
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Aug 2008
Decision
337d
Days
-
Risk

K072486 is an FDA 510(k) clearance for the MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hem Con Medical Technologies, Inc. (Portland, US). The FDA issued a Cleared decision on August 6, 2008 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

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FDA 510(k) Submission Details - K072486

510(k) Number K072486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2007
Decision Date August 06, 2008
Days to Decision 337 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
222d slower than avg
Panel avg: 115d · This submission: 337d
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 47
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