LotusCatheter (Lotus No Balloon Catheter)— 510(k) K191512

Unknown

Hakki Medical Technologies, Inc.

FDA 510(k) clearance K191512 for LotusCatheter (Lotus No Balloon Catheter), Unknown on 2020-05-21. Applicant: Hakki Medical Technologies, Inc..

Clearance details

Applicant: Hakki Medical Technologies, Inc.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 2019-06-07
Decision date: 2020-05-21
Decision: Unknown
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GBM

product code GBM

Injury: 397
Malfunction: 1,404
Total: 1,801

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.