EndoflipTM 300
FDA 510(k) clearance K223705 · decided 2023-04-14
Clearance details
- K-number
- K223705
- Device name
- EndoflipTM 300
- Applicant
- Covidien, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-12-12
- Decision date
- 2023-04-14
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- FFX
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
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| Solar Compact (G4-1) (K240007) | Laborie Medical Technologies, Corp. | 2024-05-06 |
| EndoflipTM 300 System (K231861) | Covidien, LLC | 2023-07-21 |
| Transit-Pellets (K222000) | Medifactia AB | 2023-01-18 |
| IntraMarX 3D Radiopaque Marker (K201106) | Anx Robotica Corp | 2020-05-21 |
| IntraMarX Radiopaque Markers (K191087) | Anx Robotica Corp | 2019-12-18 |
| Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe (K190208) | Diversatek Healthcare | 2019-10-03 |
| Transit-Pellets (K181760) | Medifactia AB | 2019-08-08 |
| EndoFLIP System (K183072) | Crospon, Ltd. | 2019-02-15 |
| SITZMARKS (K181750) | Konsyl Pharmaceuticals | 2018-11-15 |
| EndoFLIP® System with FLIP Topography module (K170833) | Crospon, Ltd. | 2017-04-17 |
| Rapid Barostat Bag (RBB) Pump and Catheter (K160287) | Mui Scientific | 2017-03-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S012) | Covidien, LLC | 2005-06-24 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S011) | Covidien, LLC | 2005-02-25 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S006) | Covidien, LLC | 2003-01-07 |
| OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S009) | Covidien, LLC | 2002-11-25 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S008) | Covidien, LLC | 2002-11-25 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S010) | Covidien, LLC | 2002-11-15 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S005) | Covidien, LLC | 2002-06-28 |
| OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S007) | Covidien, LLC | 2002-04-18 |