EndoFLIP System
FDA 510(k) clearance K183072 · decided 2019-02-15
Clearance details
- K-number
- K183072
- Device name
- EndoFLIP System
- Applicant
- Crospon, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-11-05
- Decision date
- 2019-02-15
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- FFX
- Device class
- 2
- Regulation number
- 876.1725
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Galway, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFU recall (Z-2950-2026) | Covidien, LLC | 2026-08-14 |