K213015 is an FDA 510(k) clearance for the DORA Disposable A.V. Fistula Needle Sets, a Needle, Fistula (Class II — Special Controls, product code FIE), submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on April 8, 2022, 200 days after receiving the submission on September 20, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K213015 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 20, 2021 |
| Decision Date | April 08, 2022 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIE — Needle, Fistula |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5540 |