PENTAX FD-34A DUODENOFIBERSCOPE— 510(k) K832006

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K832006 for PENTAX FD-34A DUODENOFIBERSCOPE, Substantially Equivalent on 1983-08-01. Applicant: Pentax Precision Instrument Corp..

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code FDT
Advisory panel: Gastroenterology, Urology
Date received: 1983-06-23
Decision date: 1983-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FDT

product code FDT

Death: 86
Injury: 1,954
Malfunction: 14,912
Total: 16,952

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.