OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818— 510(k) K990509

Name: FDA 510(k) clearance K990509
Creator: U.S. Food and Drug Administration
Published: 1999-05-18

Substantially Equivalent

Implemed, Inc.

FDA 510(k) clearance K990509 for OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818, Substantially Equivalent on 1999-05-18. Applicant: Implemed, Inc.. Device class: 2.

Clearance details

Applicant: Implemed, Inc.
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1999-02-18
Decision date: 1999-05-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Watertown, MA, US

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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.