ESOFLIP ES
FDA 510(k) clearance K142000 · decided 2014-09-25
Clearance details
- K-number
- K142000
- Device name
- ESOFLIP ES
- Applicant
- Crospon, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-23
- Decision date
- 2014-09-25
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- PIE
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bonita Springs, FL, US
- 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-310 Balloon Catheter (K172128) | Crospon, Ltd. | 2017-11-22 |
Recalls involving this device
No recalls on record reference this clearance.