K233094 is an FDA 510(k) clearance for the Wellead® Latex Foley Catheter. This device is classified as a Catheter, Urological (antimicrobial) And Accessories (Class II - Special Controls, product code MJC).
Submitted by Well Lead Medical (Hainan) Co., Ltd. (Haikou, CN). The FDA issued a Cleared decision on June 6, 2024, 254 days after receiving the submission on September 26, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K233094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2023 |
| Decision Date | June 06, 2024 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MJC - Catheter, Urological (antimicrobial) And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |