Frova Intubating Introducer
FDA 510(k) clearance K161813 · decided 2017-05-19
Clearance details
- K-number
- K161813
- Device name
- Frova Intubating Introducer
- Applicant
- William Cook Europe Aps
- Decision
- Substantially Equivalent
- Date received
- 2016-07-01
- Decision date
- 2017-05-19
- Days to decision
- 322 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bjaeverskov, DK
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Zenith Dissection Endovascular System (P180001/S015) | William Cook Europe Aps | 2025-05-19 |
| Zenith Dissection Endovascular System (P180001/S014) | William Cook Europe Aps | 2024-07-19 |
| Zenith Dissection Endovascular System (P180001/S013) | William Cook Europe Aps | 2024-07-09 |
| Zenith Dissection Endovascular System (P180001/S012) | William Cook Europe Aps | 2024-04-29 |
| Zenith® Dissection Endovascular System (P180001/S010) | William Cook Europe Aps | 2023-12-15 |
| Zenith® Dissection Endovascular System (P180001/S008) | William Cook Europe Aps | 2023-12-14 |
| Zenith® Dissection Endovascular System (P180001/S009) | William Cook Europe Aps | 2023-12-13 |
| Zenith Dissection Endovascular System (P180001/S007) | William Cook Europe Aps | 2023-06-07 |