Jimmy John III Rectal Nozzle
FDA 510(k) K973256 · Colon Therapeutics
510(k) numberK973256
Submission
- Device name
- Jimmy John III Rectal Nozzle
- Applicant
- Colon Therapeutics
Groves, TX, US - Received
- August 25, 1997
- Decision date
- September 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KPL – Colonic Irrigation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5220
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K201861 | Bio Fluff SystemKPL · Traditional | Gnali Bocia S.R.L. | 03/02/2022SE |
| K180800 | Colonic Plus Regular, Small, and Straight Shape HydrokitKPL · Traditional | Colonic Plus | 06/01/2018SESK |
| K152834 | Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar…KPL · Traditional | Colonplus Equipments & Speculums, S.L. | 08/10/2016SE |
| K150381 | Aqua CleanseKPL · Traditional | Quality Medical Supply, Inc. | 09/11/2015SE |
| K131852 | HC-1 and HC-1 ClassicKPL · Traditional | Transcendencias Comerciales SL Transcom | 04/17/2014SE |
| K094022 | The Water LilyKPL · Traditional | Clearwater Products, LLC | 06/11/2010SE |
| K071057 | Colonic & Enema NozzleKPL · Traditional | Tiller Mind Body, Inc. | 10/05/2007SE |
| K051344 | Colonic and Enema NozzleKPL · Special | Ultimate Concepts, Inc. | 08/18/2005SE |
| K050992 | Conmed Irrigation NozzleKPL · Traditional | Conmedcorp | 07/14/2005SE |
| K050112 | Pro Fit Disposable Rectal Speculum, Models 8116 and 8117KPL · Traditional | Prime Pacific Health Innovations Corporation | 03/15/2005SE |
More from Prime Pacific Health Innovations Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K972455 | Jimmy John III Rectal Nozzel, Model CitKPL · Traditional | 09/09/1997SE |
| K881720 | Jimmy John IIIKPL · Traditional | 07/20/1988SE |
| K873948 | Modified Rectal NozzleKPL · Traditional | 10/14/1987SE |
| K870376 | Jimmy John III, Colonic Irrigation SystemKPL · Traditional | 03/17/1987SE |
| K870127 | Modified Jimmy John IIIKPL · Traditional | 03/17/1987SE |
| K860943 | Jimmy John III, Rectal Nozzle (Modification)KPL · Traditional | 05/15/1986SE |
| K842083 | Jimmy John IIIKPL · Traditional | 10/24/1984SE |
Questions and answers
When was Jimmy John III Rectal Nozzle cleared by the FDA?
Jimmy John III Rectal Nozzle (K973256) received a 510(k) decision of Substantially Equivalent on September 29, 1997, 35 days after the submission was received.
What is the product code of K973256?
The FDA product code is KPL – Colonic Irrigation System, a Class II (moderate risk) device regulated under 21 CFR 876.5220.