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510(k) K050112

PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 by Prime Pacific Health Innovations Corporation — Product Code KPL

K050112 is an FDA 510(k) premarket notification submitted by Prime Pacific Health Innovations Corporation for the device "PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117". The FDA issued a decision of Substantially Equivalent on March 15, 2005. The device falls under product code KPL (Colonic Irrigation System), a Class II device regulated under 21 CFR 876.5220. Prime Pacific Health Innovations Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2005
Date Received
January 18, 2005
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 Prime Pacific Health Innovations Corporation

  • K000031 — AQUANET, MODEL EC 2000 (September 10, 2001)

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)
  • K051344 — COLONIC AND ENEMA NOZZLE (August 18, 2005)
  • K050992 — CONMED IRRIGATION NOZZLE (July 14, 2005)
  • K033149 — ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM (March 23, 2004)

FDA data resources