510(k) K122440
K122440 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "RESTORELLE L". The FDA issued a decision of Substantially Equivalent on November 19, 2012. The device falls under product code OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed), a Class II device regulated under 21 CFR 878.3300. Coloplast Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2012
- Date Received
- August 10, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OB
- Submission Type
Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.