FC-38TLH, FIBER COLONOSCOPE— 510(k) K951575

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K951575 for FC-38TLH, FIBER COLONOSCOPE, Substantially Equivalent on 1995-06-27. Applicant: Pentax Precision Instrument Corp..

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 1995-04-04
Decision date: 1995-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miramar, FL, US

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Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.