Cleared Special

K061767 - QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+

K061767 · 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
Jul 2006
Decision
26d
Days
-
Risk

K061767 is an FDA 510(k) clearance for the QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+. 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 July 19, 2006 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K061767

510(k) Number K061767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2006
Decision Date July 19, 2006
Days to Decision 26 days
Submission Type Special
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
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 K061767.
TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM
K070211 · Hemostasis, LLC · Apr 2007
QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER
K070010 · Z-Medica Corporation · Jan 2007
BLOXX RAPID CLOTTING AGENT
K061722 · Crosslink-D, Inc. · Aug 2006
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
K061079 · Medtrade Products , Ltd. · Jun 2006
HEMOHALT HEMOSTASIS PAD
K060409 · Vanson-Halosource, Inc. · May 2006
QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE
K051955 · Z-Medica Corporation · Aug 2005
K061767 · QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
Download PDF FDA Summary Z-Medica Corporation