UROSCOPE, ARTES MEDICAL, USA— 510(k) K003988

Substantially Equivalent

Artes Medical USA, Inc.

FDA 510(k) clearance K003988 for UROSCOPE, ARTES MEDICAL, USA, Substantially Equivalent on 2001-09-06. Applicant: Artes Medical USA, Inc..

Clearance details

Applicant: Artes Medical USA, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2000-12-26
Decision date: 2001-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.