FB-18X, FIBER BRONCHOSCOPE— 510(k) K951199

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K951199 for FB-18X, FIBER BRONCHOSCOPE, Substantially Equivalent on 1995-04-10. Applicant: Pentax Precision Instrument Corp..

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 1995-03-16
Decision date: 1995-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miramar, FL, US

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Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.