STERILE URETHRAL CATHETER KIT— 510(k) K760897

Name: FDA 510(k) clearance K760897
Creator: U.S. Food and Drug Administration
Published: 1978-08-31

Substantially Equivalent

Diamed Division Ill. Tool Works, Inc.

FDA 510(k) clearance K760897 for STERILE URETHRAL CATHETER KIT, Substantially Equivalent on 1978-08-31. Applicant: Diamed Division Ill. Tool Works, Inc.. Device class: 2.

Clearance details

Applicant: Diamed Division Ill. Tool Works, Inc.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1976-10-26
Decision date: 1978-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Diamed Division Ill. Tool Works, Inc.

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K854953 — DIAMED MODELS 600, 900, 960, 9641986-04-22
K823450 — FEMALE EXTERNAL URINARY APPLIANCE1982-12-28
K812281 — TOUCHLESS HOME-CATH1981-10-13
K802664 — URINARY DRAINAGE UNT1980-11-12
K802665 — TOUCHLESS CLEAN-CATH1980-11-12

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.