DeviceClearance

COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter— 510(k) K180738

Substantially Equivalent

Compactcath, Inc.

FDA 510(k) clearance K180738 for COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter, Substantially Equivalent on 2018-06-14. Applicant: Compactcath, Inc.. Device class: 2.

Clearance details

Applicant
Compactcath, Inc.
Product code
Code EZD
Device class
Class 2
Regulation
21 CFR 876.5130
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Palo Alto, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EZD

product code EZD
Injury
864
Malfunction
2,210
Total
3,074

Source: openFDA MAUDE database, through . 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.