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510(k) K873948

MODIFIED RECTAL NOZZLE by Colon Therapeutics — Product Code KPL

K873948 is an FDA 510(k) premarket notification submitted by Colon Therapeutics for the device "MODIFIED RECTAL NOZZLE". The FDA issued a decision of Substantially Equivalent on October 14, 1987. The device falls under product code KPL (Colonic Irrigation System), a Class II device regulated under 21 CFR 876.5220. Colon Therapeutics has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1987
Date Received
September 28, 1987
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 Colon Therapeutics

  • K973256 — JIMMY JOHN III RECTAL NOZZLE (September 29, 1997)
  • K972455 — JIMMY JOHN III RECTAL NOZZEL, MODEL CIT (September 9, 1997)
  • K881720 — JIMMY JOHN III (July 20, 1988)
  • K870127 — MODIFIED JIMMY JOHN III (March 17, 1987)
  • K870376 — JIMMY JOHN III, COLONIC IRRIGATION SYSTEM (March 17, 1987)
  • K860943 — JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION) (May 15, 1986)
  • K842083 — JIMMY JOHN III (October 24, 1984)

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)
  • K050112 — PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 (March 15, 2005)

FDA data resources