K111405 is an FDA 510(k) clearance for the BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,. This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by Hangzhou Bever Medical Devices Co., Ltd. (Hangzhou, Zhejiang, CN). The FDA issued a Cleared decision on February 13, 2012, 270 days after receiving the submission on May 19, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K111405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2011 |
| Decision Date | February 13, 2012 |
| Days to Decision | 270 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 |