The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Flexor Ureteral Access Sheath And Flexor Parallel Rapid Release Ureteral Access Sheath.
| Device ID | K172217 |
| 510k Number | K172217 |
| Device Name: | Flexor Ureteral Access Sheath And Flexor Parallel Rapid Release Ureteral Access Sheath |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Andrew Breidenbach |
| Correspondent | Andrew Breidenbach Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-24 |
| Decision Date | 2017-12-13 |
| Summary: | summary |