MEDIVISION CYSTOSCOPE— 510(k) K982620

Substantially Equivalent

Medivision Scope Service Center, Inc.

FDA 510(k) clearance K982620 for MEDIVISION CYSTOSCOPE, Substantially Equivalent on 1998-09-30. Applicant: Medivision Scope Service Center, Inc..

Clearance details

Applicant: Medivision Scope Service Center, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 1998-07-27
Decision date: 1998-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

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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.