URETERAL STONE DISLODGER— 510(k) K851922

Substantially Equivalent

Inter-Med Corp.

FDA 510(k) clearance K851922 for URETERAL STONE DISLODGER, Substantially Equivalent on 1985-08-02. Applicant: Inter-Med Corp..

Clearance details

Applicant: Inter-Med Corp.
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1985-05-02
Decision date: 1985-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danielson, CT, 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.