FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE— 510(k) K951191

Substantially Equivalent

Pentax Precision Instrument Corp.

FDA 510(k) clearance K951191 for FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE, Substantially Equivalent on 1995-05-30. Applicant: Pentax Precision Instrument Corp..

Clearance details

Applicant: Pentax Precision Instrument Corp.
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 1995-03-16
Decision date: 1995-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miramar, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FBN

product code FBN

Death: 8
Malfunction: 951
Total: 959

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.