MODIFICATION TO FOSSA URETERAL STONE SWEEPER— 510(k) K031292

Substantially Equivalent

Fossa Medical, Inc.

FDA 510(k) clearance K031292 for MODIFICATION TO FOSSA URETERAL STONE SWEEPER, Substantially Equivalent on 2003-05-22. Applicant: Fossa Medical, Inc..

Clearance details

Applicant: Fossa Medical, Inc.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2003-04-23
Decision date: 2003-05-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Ayer, MA, US

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Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.