FDA Product Code PBQ: Fixation, Non-absorbable Or Absorbable, For Pelvic Use
Attaching Suture Or Stapling Ligaments Of The Pelvic Floor.
Leading manufacturers include Escala Medical, Coloplast A/S and Escala Medical, Ltd..
8
Total
8
Cleared
128d
Avg days
2004
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
27d
recently vs 142d historically
FDA 510(k) Cleared Fixation, Non-absorbable Or Absorbable, For Pelvic Use Devices (Product Code PBQ)
8 devices
Cleared
Mar 04, 2026
Mendit
Escala Medical, Ltd.
Obstetrics & Gynecology
27d
Cleared
Jul 25, 2023
Apyx
Escala Medical
Obstetrics & Gynecology
131d
Cleared
Jun 10, 2022
Saffron Fixation System
Coloplast A/S
Obstetrics & Gynecology
116d
Cleared
Apr 05, 2022
Apyx
Escala Medical
Obstetrics & Gynecology
123d
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 remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - PBQ Product Code
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 →