UROLOGICAL STONE BASKET— 510(k) K891254

Substantially Equivalent

Northgate Research, Inc.

FDA 510(k) clearance K891254 for UROLOGICAL STONE BASKET, Substantially Equivalent on 1989-03-22. Applicant: Northgate Research, Inc..

Clearance details

Applicant: Northgate Research, Inc.
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-08
Decision date: 1989-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, 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.