510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974419Substantially Equivalent

Rusch Simplastic Councill Tip Catheter

Rusch, Inc., Duluth GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974419 is the FDA 510(k) clearance record for RUSCH SIMPLASTIC COUNCILL TIP CATHETER, a class II device, cleared for Rusch, Inc. on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list 6 510(k) clearances for Rusch, Inc., from to . As of , FDA records show no recalls naming K974419.

Clearance record

Decision date
Received
(64 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, Inc. 2450 Meadowbrook Pkwy., Duluth GA
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