The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Proxis Ureteral Access Sheath.
| Device ID | K160861 |
| 510k Number | K160861 |
| Device Name: | Proxis Ureteral Access Sheath |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | C.R. Bard, Inc. 8195 Industrial Blvd Covington, GA 30014 |
| Contact | Beatrice Wan |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-03-29 |
| Decision Date | 2016-03-31 |
| Summary: | summary |