Cleared Traditional

K120782 - INTERVENTIONAL HEMOSTATIC BANDAGE

K120782 · Z-Medica Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
370d
Days
-
Risk

K120782 is an FDA 510(k) clearance for the INTERVENTIONAL HEMOSTATIC BANDAGE. 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 March 20, 2013 after a review of 370 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.

View all Z-Medica Corporation devices

FDA 510(k) Submission Details - K120782

510(k) Number K120782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2012
Decision Date March 20, 2013
Days to Decision 370 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
255d slower than avg
Panel avg: 115d · This submission: 370d
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
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K120782.
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BONDILOXS TOPICAL HEMOSTATIC DRESSING
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CELOX GAUZE PRO
K113560 · Medtrade Products , Ltd. · Aug 2012
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
K112800 · Huizhou Foryou Medical Devices Co., Ltd. · May 2012
CELOX RAPID GAUZE
K110386 · Medtrade Products , Ltd. · May 2011