Cleared Traditional

K143462 - AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)

K143462 · Benq Materials Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
155d
Days
-
Risk

K143462 is an FDA 510(k) clearance for the AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the.... Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Benq Materials Corporation (Taoyuan, TW). The FDA issued a Cleared decision on May 8, 2015 after a review of 155 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Benq Materials Corporation devices

FDA 510(k) Submission Details - K143462

510(k) Number K143462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2014
Decision Date May 08, 2015
Days to Decision 155 days
Submission Type Traditional
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
40d slower than avg
Panel avg: 115d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

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 Consultant

Acmebiotechs Co., Ltd.
Kenix Chang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 118
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K143462.
AnsCare ChitoClot Pad
K150963 · Benq Materials Corporation · Nov 2015
HEMO-Bandage
K151204 · Coreleader Biotech Co., Ltd. · Jul 2015
Hemogrip Patch
K143466 · Remedium Technologies, Inc. · Jun 2015
NUSTAT, NUSTAT XR
K142363 · Beeken Biomedical · Jan 2015
WOUNDCLOT HEMOSTATIC GAUZE
K140573 · Core Scientific , Ltd. · Nov 2014
STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM
K140313 · Coag Medical, LLC · Jul 2014