EndoFLIP® System with FLIP Topography module
FDA 510(k) K170833 · Crospon, Ltd.
510(k) numberK170833
Submission
- Device name
- EndoFLIP® System with FLIP Topography module
- Applicant
- Crospon, Ltd.
Galway, IE - Received
- March 20, 2017
- Decision date
- April 17, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) ProbeFFX · Traditional | Diversatek Healthcare | 10/03/2019SE |
| K181760 | Transit-PelletsFFX · Traditional | Medifactia AB | 08/08/2019SE |
| K183072 | EndoFLIP SystemFFX · Traditional | Crospon, Ltd. | 02/15/2019SE |
More from Crospon, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K183072 | EndoFLIP SystemFFX · Traditional | 02/15/2019SE |
| K172128 | EsoFLIP® ES-310 Balloon CatheterPIE · Traditional | 11/22/2017SE |
| K160725 | EndoFLIPFFX · Traditional | 05/01/2016SE |
| K142000 | Esoflip EsPIE · Traditional | 09/25/2014SE |
| K132337 | Esoflip Balloon Dilation CatheterPID · Traditional | 10/07/2013SE |
| K130906 | Endoflip CatheterFFX · Traditional | 07/17/2013SE |
| K120997 | Barostat Software OptionFFX · Traditional | 08/27/2012SE |
| K110531 | Endoflip EcdFED · Traditional | 10/06/2011SE |
| K110529 | Endoflip Gastric TubeKNT · Traditional | 07/22/2011SE |
| K102214 | Endo FlipFFX · Traditional | 12/16/2010SE |
Questions and answers
When was EndoFLIP® System with FLIP Topography module cleared by the FDA?
EndoFLIP® System with FLIP Topography module (K170833) received a 510(k) decision of Substantially Equivalent on April 17, 2017, 28 days after the submission was received.
What is the product code of K170833?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.