Cleared Special

K111163 - CHITOGAUZE FUSION

K111163 · Hem Con Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
21d
Days
-
Risk

K111163 is an FDA 510(k) clearance for the CHITOGAUZE FUSION. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hem Con Medical Technologies, Inc. (Portland, US). The FDA issued a Cleared decision on May 17, 2011 after a review of 21 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.

View all Hem Con Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K111163

510(k) Number K111163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2011
Decision Date May 17, 2011
Days to Decision 21 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
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 47
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K111163.
BONDILOXS TOPICAL HEMOSTATIC DRESSING
K132333 · Medtrade Products , Ltd. · Jun 2014
CELOX GAUZE PRO
K113560 · Medtrade Products , Ltd. · Aug 2012
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
K112800 · Huizhou Foryou Medical Devices Co., Ltd. · May 2012
CELOX RAPID GAUZE
K110386 · Medtrade Products , Ltd. · May 2011
CELSTAT
K103245 · Baxter Healthcare Corp · Mar 2011
CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI
K102965 · Medtrade Products , Ltd. · Dec 2010