FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE— 510(k) K961974

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K961974 for FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE, Substantially Equivalent on 1997-02-10. Applicant: Pentax Precision Instrument Corp..

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1996-05-20
Decision date: 1997-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miramar, FL, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.