Cleared Traditional

K120782 - INTERVENTIONAL HEMOSTATIC BANDAGE

K120782 · 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
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.

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
Combination Product No
PCCP Authorized No
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 126
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K120782.
PERCLOT TOPICAL
K132105 · Cryolife, Inc. · Apr 2014
STATSEAL DISC
K130324 · Biolife, LLC · Jul 2013
QUIKCLOT HEMOSTATIC DRESSING
K123387 · Z-Medica, LLC · Apr 2013
NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
K122886 · Hemostasis, LLC · Nov 2012
GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
K121485 · Hemcon Medical Technologies Europe, Ltd. · Aug 2012
SOFTSEAL-C
K112864 · Chitogen, Inc. · Aug 2012
K120782 · INTERVENTIONAL HEMOSTATIC BANDAGE
Download PDF FDA Summary Z-Medica Corporation