METEL URETERAL BASKET STONE DISLODGER— 510(k) K951761

Substantially Equivalent

Annex Medical, Inc.

FDA 510(k) clearance K951761 for METEL URETERAL BASKET STONE DISLODGER, Substantially Equivalent on 1995-05-11. Applicant: Annex Medical, Inc..

Clearance details

Applicant: Annex Medical, Inc.
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1995-04-17
Decision date: 1995-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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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.