FDA Product Code KPL: Colonic Irrigation System
Leading manufacturers include Gnali Bocia S.R.L. and Colonic Plus.
40
Total
40
Cleared
197d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Colonic Irrigation System Devices (Product Code KPL)
40 devices
Cleared
Mar 02, 2022
Bio Fluff System
Gnali Bocia S.R.L.
Gastroenterology & Urology
604d
Cleared
Jun 01, 2018
Colonic Plus Regular, Small, and Straight Shape Hydrokit
Colonic Plus
Gastroenterology & Urology
66d
About Product Code KPL - Regulatory Context
510(k) Submission Activity
40 total 510(k) submissions under product code KPL since 1977, with 40 receiving FDA clearance (average review time: 197 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.