FDA Product Code PBQ: Fixation, Non-absorbable Or Absorbable, For Pelvic Use
Attaching Suture Or Stapling Ligaments Of The Pelvic Floor.
Leading manufacturers include Coloplast A/S and Escala Medical, Ltd..
FDA 510(k) Cleared Fixation, Non-absorbable Or Absorbable, For Pelvic Use Devices (Product Code PBQ)
About Product Code PBQ - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PBQ since 2004, with 8 receiving FDA clearance (average review time: 128 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under PBQ have taken an average of 27 days to reach a decision - down from 142 days historically, suggesting improved FDA processing for this classification.
PBQ devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →