CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200— 510(k) K884025

Substantially Equivalent

Circon Acmi

FDA 510(k) clearance K884025 for CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200, Substantially Equivalent on 1989-03-03. Applicant: Circon Acmi.

Clearance details

Applicant: Circon Acmi
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 1988-09-22
Decision date: 1989-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.