510(k) K172060
K172060 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Capio SLIM Suture Capturing Device". The FDA issued a decision of Substantially Equivalent on Nov 3, 2017. The device falls under product code PWI (Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse), a Class II device regulated under 21 CFR 884.4910. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 3, 2017
- Date Received
- Jul 7, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
- Device Class
- Class II
- Regulation Number
- 884.4910
- Review Panel
- OB
- Submission Type
- 510(k)
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair