510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K143462Substantially Equivalent

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

Benq Materials Corporation, Taoyuan, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143462 is the FDA 510(k) clearance record for AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use), cleared for Benq Materials Corporation on under FDA product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics). FDA's definition for product code QSY reads: "To temporarily control bleeding and cover external wounds". FDA records list 4 510(k) clearances for Benq Materials Corporation, from to . As of , FDA records show no recalls naming K143462.

Clearance record

Decision date
Received
(155 days to decision)
Product code
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device class
Unclassified
Review panel
Unknown
Applicant
Benq Materials Corporation 29 Jianguo E. Rd., Guishan, Taoyuan, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSY

Trailing 12 months
4 clearances under product code QSY in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QSY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260