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510(k) K201861

Bio Fluff System by Gnali Bocia S.R.L. — Product Code KPL

K201861 is an FDA 510(k) premarket notification submitted by Gnali Bocia S.R.L. for the device "Bio Fluff System". The FDA issued a decision of Substantially Equivalent on March 2, 2022. The device falls under product code KPL (Colonic Irrigation System), a Class II device regulated under 21 CFR 876.5220.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2022
Date Received
July 6, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colonic Irrigation System
Device Class
Class II
Regulation Number
876.5220
Review Panel
GU
Submission Type

Other clearances for product code KPL

  • K180800 — Colonic Plus Regular, Small, and Straight Shape Hydrokit (June 1, 2018)
  • K152834 — Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop (August 10, 2016)
  • K150381 — AQUA CLEANSE (September 11, 2015)
  • K131852 — HC-1 AND HC-1 CLASSIC (April 17, 2014)
  • K094022 — THE WATER LILY (June 11, 2010)
  • K071057 — COLONIC & ENEMA NOZZLE (October 5, 2007)
  • K051344 — COLONIC AND ENEMA NOZZLE (August 18, 2005)
  • K050992 — CONMED IRRIGATION NOZZLE (July 14, 2005)
  • K050112 — PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 (March 15, 2005)
  • K033149 — ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM (March 23, 2004)

FDA data resources