510(k) K252605
- Device
- mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
- Applicant
- Medspira, LLC
- 510(k) number
- K252605
- Product code
- FFX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-05
- Date received
- 2025-08-18
- Regulation
- 876.1725
- Classification name
- System, Gastrointestinal Motility (Electrical)
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Evan Johnston
- Address
- 2718 Summer St. NE Minneapolis MN US 55413 55413
FDA Registration Numbers#
- 1123137
- 3010381606
- 3012480535
- 3008717264
- 3015198783
- 8020893
- 3007662958
- 9611668
- 3004904811
- 3009106214
- 3002821211
- 3011790297
- 3035451914
- 3010082909
- 3016544248
- 9611896
- 9710107
- 3018094310
- 3012302888
- 3008361498
- 1836324
- 2023374
- 9681384
- 3016854619
- 3002806603
- 3013973539
- 3008414621
- 3009445917
- 3017448360
- 1126271
- 1119033
Source Documents#
Other 510(k) Records For Product Code FFX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240007 | Solar Compact (G4-1) | Laborie Medical Technologies, Corp. | 2024-05-06 |
| K231861 | EndoflipTM 300 System | Covidien, LLC | 2023-07-21 |
| K223705 | EndoflipTM 300 | Covidien, LLC | 2023-04-14 |
| K222000 | Transit-Pellets | Medifactia AB | 2023-01-18 |
| K201106 | IntraMarX 3D Radiopaque Marker | Anx Robotica Corp | 2020-05-21 |
| K191087 | IntraMarX Radiopaque Markers | Anx Robotica Corp | 2019-12-18 |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe | Diversatek Healthcare | 2019-10-03 |
| K181760 | Transit-Pellets | Medifactia AB | 2019-08-08 |
| K183072 | EndoFLIP System | Crospon, Ltd. | 2019-02-15 |
| K181750 | SITZMARKS | Konsyl Pharmaceuticals | 2018-11-15 |
| K170833 | EndoFLIP® System with FLIP Topography module | Crospon, Ltd. | 2017-04-17 |
| K160287 | Rapid Barostat Bag (RBB) Pump and Catheter | Mui Scientific | 2017-03-14 |
| K160170 | Lehman Manometry Catheter | Wilson-Cook Medical, Inc. | 2016-06-20 |
| K160725 | EndoFLIP | Crospon, Ltd. | 2016-05-01 |
| K151086 | ManoScan System | Given Imaging , Ltd. | 2016-04-28 |