EsoFLIP® ES-310 Balloon Catheter
FDA 510(k) clearance K172128 · decided 2017-11-22
Clearance details
- K-number
- K172128
- Device name
- EsoFLIP® ES-310 Balloon Catheter
- Applicant
- Crospon, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-07-14
- Decision date
- 2017-11-22
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- PIE
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Galway, IE
- 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.
| Record | Firm | Date |
|---|---|---|
| ESOFLIP ES (K142000) | Crospon, Ltd. | 2014-09-25 |
Recalls involving this device
No recalls on record reference this clearance.