510(k) K173501
K173501 is an FDA 510(k) premarket notification submitted by Coloplast for the device "Meridian Vaginal Positioning System (VPS)". The FDA issued a decision of Substantially Equivalent on February 9, 2018. The device falls under product code PWK (Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse), a Class II device regulated under 21 CFR 884.4910. Coloplast has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2018
- Date Received
- November 13, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
- Device Class
- Class II
- Regulation Number
- 884.4910
- Review Panel
- OB
- Submission Type
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair