Cleared Traditional

K053644 - THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT

K053644 · Vascular Solutions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
41d
Days
-
Risk

K053644 is an FDA 510(k) clearance for the THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT. Classified as Hemostatic Wound Dressing With Thrombin Or Other Biologics (product code QSX).

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 9, 2006 after a review of 41 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.

View all Vascular Solutions, Inc. devices

Submission Details

510(k) Number K053644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2005
Decision Date February 09, 2006
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Regulatory Peers - QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics

All 17
Devices cleared under the same product code (QSX) and FDA review panel - the closest regulatory comparables to K053644.
THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT
K070938 · Vascular Solutions, Inc. · Aug 2007
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
K063860 · Vascular Solutions, Inc. · Feb 2007
D-STAT DRY HEMOSTATIC BANDAGE
K061219 · Vascular Solutions, Inc. · Oct 2006
THROMBIX 3X3 HEMOSTATIC PAD
K053054 · Vascular Solutions, Inc. · Nov 2005
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
K050511 · Vascular Solutions, Inc. · Apr 2005
D-STAT RADIAL HEMOSTATIC BAND
K050133 · Vascular Solutions, Inc. · Feb 2005