Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

OTO · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.3300

Classification

FDA Product Code: OTO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.3300
Review panel: OB
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.

Market data

Cleared 510(k) submissions: 23
Registered establishments: 18

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown