SYMPACATH HYDROGEL COATED FOLEY— 510(k) K964575

Name: FDA 510(k) clearance K964575
Creator: U.S. Food and Drug Administration
Published: 1997-02-04

Substantially Equivalent

Rusch Intl.

FDA 510(k) clearance K964575 for SYMPACATH HYDROGEL COATED FOLEY, Substantially Equivalent on 1997-02-04. Applicant: Rusch Intl.. Device class: 2.

Clearance details

Applicant: Rusch Intl.
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1996-11-14
Decision date: 1997-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, US

Download summary PDF View on FDA.gov ↗

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K241424 — InnoCare Specialty Foley Catheter2024-09-18
K232469 — Rüsch Latex Gold Foley Catheter2024-08-01

More clearances from Rusch Intl.

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K033023 — INTERMITTENT URETHRAL CATHETERS2003-12-23
K030559 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM2003-06-30
K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER2003-06-17
K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS2003-03-28
K023964 — RUSCH MICROLARYNGEAL TUBE2002-12-23

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.