MANAN PROSTATIC BIOPSY NEEDLE— 510(k) K895897

Substantially Equivalent

Manan Medical Products, Inc.

FDA 510(k) clearance K895897 for MANAN PROSTATIC BIOPSY NEEDLE, Substantially Equivalent on 1989-10-18. Applicant: Manan Medical Products, Inc..

Clearance details

Applicant: Manan Medical Products, Inc.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 1989-10-06
Decision date: 1989-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.