CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20— 510(k) K884252

Substantially Equivalent

Circon Acmi

FDA 510(k) clearance K884252 for CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20, Substantially Equivalent on 1989-01-10. Applicant: Circon Acmi.

Clearance details

Applicant: Circon Acmi
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 1988-10-11
Decision date: 1989-01-10
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.