Cytosponge Cell Collection Device
FDA 510(k) clearance K181020 · decided 2018-08-16
Clearance details
- K-number
- K181020
- Device name
- Cytosponge Cell Collection Device
- Applicant
- Covidien, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-04-17
- Decision date
- 2018-08-16
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- EOX
- Device class
- 2
- Regulation number
- 874.4710
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Co recall (Z-2282-2023) | Covidien, LLC | 2023-08-02 |
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 |