Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
The Mesh, Surgical, Non-Synthetic, Urogynecologic, for Apical Vaginal and Uterine Prolapse, Transabdominally Placed is a non-synthetic surgical mesh implant used as a bridging material to attach the vaginal apex or uterus to the sacral promontory in abdominal, laparoscopic, or robot-assisted sacrocolpopexy procedures. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is PAJ, with regulation number 878.3300 under the General, Plastic Surgery specialty, reviewed by the obstetrics/gynecology panel, and it carries an implant flag.
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Basic Information
- Product Code
- PAJ
- Device Class
- FDA class 2
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.