510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964575Substantially Equivalent

Sympacath Hydrogel Coated Foley

Rusch Intl., Jeffrey NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964575 is the FDA 510(k) clearance record for SYMPACATH HYDROGEL COATED FOLEY, a class II device, cleared for Rusch Intl. on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list 43 510(k) clearances for Rusch Intl., from to . As of , FDA records show no recalls naming K964575.

Clearance record

Decision date
Received
(82 days to decision)
Product code
EZL Catheter, Retention Type, Balloon
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Rusch Intl. Tall Pines Park, Jeffrey NH
510(k) summary
Summary
Third party review
No

Clearances, product code EZL

Trailing 12 months
3 clearances under product code EZL in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EZL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260