PRESCOTT'S LIGHT SOURCE MODEL NO. II-150— 510(k) K964586

Substantially Equivalent

Iba/Griffith

FDA 510(k) clearance K964586 for PRESCOTT'S LIGHT SOURCE MODEL NO. II-150, Substantially Equivalent on 1997-01-17. Applicant: Iba/Griffith.

Clearance details

Applicant: Iba/Griffith
Product code: Code FCW
Advisory panel: Gastroenterology, Urology
Date received: 1996-11-15
Decision date: 1997-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monument, CO, US

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Adverse events under product code FCW

product code FCW

Malfunction: 912
Other: 1
Total: 913

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.