Cleared Special

K070010 - QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER

K070010 · 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
Jan 2007
Decision
22d
Days
-
Risk

K070010 is an FDA 510(k) clearance for the QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER. 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 January 25, 2007 after a review of 22 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 - K070010

510(k) Number K070010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date January 25, 2007
Days to Decision 22 days
Submission Type Special
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
93d faster than avg
Panel avg: 115d · This submission: 22d
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 K070010.
HEMCON CHITOFLEX-SURGICAL DRESSING
K071519 · Hemcon, Inc. · Aug 2007
AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC
K070175 · Medtrade Products , Ltd. · Jul 2007
TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM
K070211 · Hemostasis, LLC · Apr 2007
BLOXX RAPID CLOTTING AGENT
K061722 · Crosslink-D, Inc. · Aug 2006
QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
K061767 · Z-Medica Corporation · Jul 2006
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
K061079 · Medtrade Products , Ltd. · Jun 2006
K070010 · QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER
Download PDF FDA Summary Z-Medica Corporation