K191512 is an FDA 510(k) clearance for the LotusCatheter (Lotus No Balloon Catheter). This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by Hakki Medical Technologies, Inc. (Largo, US). The FDA issued a Cleared decision on May 21, 2020, 349 days after receiving the submission on June 7, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K191512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | June 07, 2019 |
| Decision Date | May 21, 2020 |
| Days to Decision | 349 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GBM - Catheter, Urethral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |