MODEL OSP, SANDHILL AMS— 510(k) K904231

Substantially Equivalent

Sandhill Scientific, Inc.

FDA 510(k) clearance K904231 for MODEL OSP, SANDHILL AMS, Substantially Equivalent on 1991-01-02. Applicant: Sandhill Scientific, Inc..

Clearance details

Applicant: Sandhill Scientific, Inc.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 1990-08-28
Decision date: 1991-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

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.