MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM— 510(k) K030315

Substantially Equivalent

Ultroid, LLC

FDA 510(k) clearance K030315 for MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM, Substantially Equivalent on 2003-02-27. Applicant: Ultroid, LLC.

Clearance details

Applicant: Ultroid, LLC
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2003-01-30
Decision date: 2003-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Carson City, NV, 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.