510(k) K172565
K172565 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device". The FDA issued a decision of Substantially Equivalent on December 20, 2017. The device falls under product code PWJ (Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence), a Class II device regulated under 21 CFR 884.4910. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2017
- Date Received
- August 25, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
- Device Class
- Class II
- Regulation Number
- 884.4910
- Review Panel
- GU
- Submission Type
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for stress urinary incontinence