K200134 is an FDA 510(k) clearance for the Jimushi Sterile Urethral Catheter for single use. This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by Hangzhou Jimushi Meditech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 1, 2020, 132 days after receiving the submission on January 21, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K200134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2020 |
| Decision Date | June 01, 2020 |
| Days to Decision | 132 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 |