The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Advantage/advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (curved & Halo), Obtryx Ii Delivery Device (curved & Halo), Solyx Sis Delivery Device.
| Device ID | K172565 |
| 510k Number | K172565 |
| Device Name: | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device |
| Classification | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Anand Patel |
| Correspondent | Anand Patel Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | PWJ |
| CFR Regulation Number | 884.4910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-25 |
| Decision Date | 2017-12-20 |
| Summary: | summary |