510(k) K930349— STONE RETRIEVAL BASKET

Substantially Equivalent

Endomedix

Clearance details

Applicant: Endomedix
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1993-01-25
Decision date: 1993-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Adverse events under product code FFL

product code FFL

Death: 2
Injury: 270
Malfunction: 2,711
Other: 2
Total: 2,985

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.