Cleared Special

K112961 - CLO-SURPLUS P.A.D.

K112961 · Scion Cardio-Vascular, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
27d
Days
-
Risk

K112961 is an FDA 510(k) clearance for the CLO-SURPLUS P.A.D.. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Scion Cardio-Vascular, Inc. (Melbourne, US). The FDA issued a Cleared decision on October 31, 2011 after a review of 27 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 - K112961

510(k) Number K112961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2011
Decision Date October 31, 2011
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 K112961.
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
K112800 · Huizhou Foryou Medical Devices Co., Ltd. · May 2012
HEMCON HEMOSTATIC GEL
K112215 · Hemcon Medical Technologies Europe, Ltd. · Apr 2012
ADVANCED TRAUMA DRESSING (ATD)
K101257 · Nanosys, Inc. · Dec 2011
CORELEADER HEMO-PAD MODEL CPII 02030
K102944 · Coreleader Biotech Co., Ltd. · Sep 2011
GUARDACARE
K103641 · Hem Con Medical Technologies, Inc. · Jun 2011
CHITOGAUZE FUSION
K111163 · Hem Con Medical Technologies, Inc. · May 2011
K112961 · CLO-SURPLUS P.A.D.
Download PDF FDA Summary Scion Cardio-Vascular…