510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852619Substantially Equivalent

Uri-Sure

Ashai Co., Ltd., Australia, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852619 is the FDA 510(k) clearance record for URI-SURE, a class II device, cleared for Ashai Co. , Ltd. on under FDA product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter). FDA records list 12 510(k) clearances for Ashai Co. , Ltd., from to . As of , FDA records show no recalls naming K852619.

Clearance record

Decision date
Received
(68 days to decision)
Product code
KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Regulation
21 CFR 876.5250
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ashai Co. , Ltd. 620 Harris St., Australia, AU
Third party review
No

Clearances, product code KNX

Trailing 12 months

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

FDA records show no clearances under product code KNX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNX, 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