The following data is part of a premarket notification filed by Suzhou Beyo Medical Technology Co., Ltd. with the FDA for Disposable Ureteral Access Sheath.
| Device ID | K203165 |
| 510k Number | K203165 |
| Device Name: | Disposable Ureteral Access Sheath |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Suzhou Beyo Medical Technology Co., Ltd. No. 38 Beiguandu Road Suzhou, CN 215000 |
| Contact | Aline Qin |
| Correspondent | Aline Qin Suzhou Beyo Medical Technology Co., Ltd. No. 38 Beiguandu Road Suzhou, CN 215000 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-23 |
| Decision Date | 2021-04-30 |