510(k) K051190
K051190 is an FDA 510(k) premarket notification submitted by Tei Biosciences, Inc. for the device "XENFORM SOFT TISSUE REPAIR MATRIX". The FDA issued a decision of Substantially Equivalent on June 10, 2005. The device falls under product code PAJ (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed), a Class II device regulated under 21 CFR 878.3300. Tei Biosciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2005
- Date Received
- May 10, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Non-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 or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.