PENTAX FC-38LA & FC-38SA COLONOFIBER— 510(k) K822846

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K822846 for PENTAX FC-38LA & FC-38SA COLONOFIBER, Substantially Equivalent on 1982-10-22. Applicant: Pentax Precision Instrument Corp..

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 1982-09-23
Decision date: 1982-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.