KPL · Class II · 21 CFR 876.5220

FDA Product Code KPL: Colonic Irrigation System

Leading manufacturers include Gnali Bocia S.R.L..

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
1–24 of 40
Cleared Mar 02, 2022
Bio Fluff System
K201861
Gnali Bocia S.R.L.
Gastroenterology & Urology · 604d

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.

KPL devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →