Cleared Traditional

K150963 - AnsCare ChitoClot Pad

K150963 · Benq Materials Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
209d
Days
-
Risk

K150963 is an FDA 510(k) clearance for the AnsCare ChitoClot Pad. 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 November 5, 2015 after a review of 209 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 - K150963

510(k) Number K150963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2015
Decision Date November 05, 2015
Days to Decision 209 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
94d slower than avg
Panel avg: 115d · This submission: 209d
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 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 K150963.
Nustat XR
K160578 · Beeken Biomedical, LLC · Jun 2016
Prometheus ChitoGauze XR PRO
K153582 · Hem Con Medical Technologies, Inc. · May 2016
HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
K150916 · Hem Con Medical Technologies, Inc. · Nov 2015
HEMO-Bandage
K151204 · Coreleader Biotech Co., Ltd. · Jul 2015
Hemogrip Patch
K143466 · Remedium Technologies, Inc. · Jun 2015
AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)
K143462 · Benq Materials Corporation · May 2015