510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041501Substantially Equivalent

Guangzhou Fortunique Drapes, Bags and Covers

Guangzhou Fortunique, Ltd., Chester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041501 is the FDA 510(k) clearance record for GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS, a class II device, cleared for Guangzhou Fortunique , Ltd. on under FDA product code MMP (Cover, Barrier, Protective). FDA records list one 510(k) clearance for Guangzhou Fortunique , Ltd. As of , FDA records show 6 recalls naming K041501.

Clearance record

Decision date
Received
(176 days to decision)
Product code
MMP Cover, Barrier, Protective
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Guangzhou Fortunique , Ltd. 485 Laroe Rd., Chester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MMP

Trailing 12 months

FDA records hold no clearances under product code MMP in the trailing twelve months.

FDA records show no clearances under product code MMP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MMP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260