PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A— 510(k) K801223

Name: FDA 510(k) clearance K801223
Creator: U.S. Food and Drug Administration
Published: 1980-06-09

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K801223 for PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A, Substantially Equivalent on 1980-06-09. Applicant: Pentax Precision Instrument Corp.. Device class: 2.

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code FDF
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1980-05-23
Decision date: 1980-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.