ONIK-COHEN ACCESS SET— 510(k) K930608

Name: FDA 510(k) clearance K930608
Creator: U.S. Food and Drug Administration
Published: 1993-07-09

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K930608 for ONIK-COHEN ACCESS SET, Substantially Equivalent on 1993-07-09. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1993-02-05
Decision date: 1993-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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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.