510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181445Substantially Equivalent

AMSure Hydrophilic Intermittent Catheter

Amsino International, Inc., Pomona CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181445 is the FDA 510(k) clearance record for AMSure Hydrophilic Intermittent Catheter, a class II device, cleared for Amsino International, Inc. on under FDA product code EZD (Catheter, Straight). FDA records list 28 510(k) clearances for Amsino International, Inc., from to . As of , FDA records show no recalls naming K181445.

Clearance record

Decision date
Received
(122 days to decision)
Product code
EZD Catheter, Straight
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Amsino International, Inc. 708 Corporate Center Dr., Pomona CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZD

Trailing 12 months
11 clearances under product code EZD in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EZD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20261
April 20262
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260