FLEXIBLE CHOLEDOCHOSCOPE— 510(k) K901010

Substantially Equivalent

Intramed Laboratories, Inc.

FDA 510(k) clearance K901010 for FLEXIBLE CHOLEDOCHOSCOPE, Substantially Equivalent on 1990-05-22. Applicant: Intramed Laboratories, Inc..

Clearance details

Applicant: Intramed Laboratories, Inc.
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 1990-03-05
Decision date: 1990-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.