Endoflip Catheter
FDA 510(k) K130906 · Crospon, Ltd.
510(k) numberK130906
Submission
- Device name
- Endoflip Catheter
- Applicant
- Crospon, Ltd.
Bonita Springs, FL, US - Received
- April 1, 2013
- Decision date
- July 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code FFX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)FFX · Traditional | Medspira, LLC | 12/05/2025SE |
| K240007 | Solar Compact (G4-1)FFX · Traditional | Laborie Medical Technologies, Corp. | 05/06/2024SE |
| K231861 | EndoflipTM 300 SystemFFX · Special | Covidien, LLC | 07/21/2023SE |
| K223705 | EndoflipTM 300FFX · Traditional | Covidien, LLC | 04/14/2023SE |
| K222000 | Transit-PelletsFFX · Traditional | Medifactia AB | 01/18/2023SE |
| K201106 | IntraMarX 3D Radiopaque MarkerFFX · Special | Anx Robotica Corp | 05/21/2020SE |
| K191087 | IntraMarX Radiopaque MarkersFFX · Traditional | Anx Robotica Corp | 12/18/2019SE |
| 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 |
| K170833 | EndoFLIP® System with FLIP Topography moduleFFX · Special | 04/17/2017SE |
| K160725 | EndoFLIPFFX · Traditional | 05/01/2016SE |
| K142000 | Esoflip EsPIE · Traditional | 09/25/2014SE |
| K132337 | Esoflip Balloon Dilation CatheterPID · Traditional | 10/07/2013SE |
| 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 Catheter cleared by the FDA?
Endoflip Catheter (K130906) received a 510(k) decision of Substantially Equivalent on July 17, 2013, 107 days after the submission was received.
What is the product code of K130906?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.