COLONOSCOPE GUIDING TUBE DEVICE— 510(k) K884857

Substantially Equivalent

Mill-Rose Laboratory

FDA 510(k) clearance K884857 for COLONOSCOPE GUIDING TUBE DEVICE, Substantially Equivalent on 1989-03-17. Applicant: Mill-Rose Laboratory.

Clearance details

Applicant: Mill-Rose Laboratory
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 1988-11-21
Decision date: 1989-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.