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510(k) K071057

COLONIC & ENEMA NOZZLE by Tiller Mind Body, Inc. — Product Code KPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2007
Date Received
April 16, 2007
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 by Tiller Mind Body, Inc.

  • K962259 — LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE) (August 29, 1996)
  • K941279 — LOWER BOWEL EVACUATION SYSTEM (October 12, 1995)

Other clearances for product code KPL

  • K201861 — Bio Fluff System (March 2, 2022)
  • 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)
  • 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)