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510(k) K051344

COLONIC AND ENEMA NOZZLE by Ultimate Concepts, Inc. — Product Code KPL

K051344 is an FDA 510(k) premarket notification submitted by Ultimate Concepts, Inc. for the device "COLONIC AND ENEMA NOZZLE". The FDA issued a decision of Substantially Equivalent on August 18, 2005. The device falls under product code KPL (Colonic Irrigation System), a Class II device regulated under 21 CFR 876.5220. Ultimate Concepts, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2005
Date Received
May 23, 2005
Clearance Type
Special
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 Ultimate Concepts, Inc.

  • K033149 — ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM (March 23, 2004)
  • K943202 — EASSUN HI-TECH OPTICS (July 27, 1994)

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)
  • K071057 — COLONIC & ENEMA NOZZLE (October 5, 2007)
  • 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