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510(k) K180800

Colonic Plus Regular, Small, and Straight Shape Hydrokit by Colonic Plus — Product Code KPL

K180800 is an FDA 510(k) premarket notification submitted by Colonic Plus for the device "Colonic Plus Regular, Small, and Straight Shape Hydrokit". The FDA issued a decision of Substantially Equivalent (kit) on June 1, 2018. The device falls under product code KPL (Colonic Irrigation System), a Class II device regulated under 21 CFR 876.5220.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 1, 2018
Date Received
March 27, 2018
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

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  • 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