510(k) K172128
- Device
- EsoFLIP® ES-310 Balloon Catheter
- Applicant
- Crospon Ltd.
- 510(k) number
- K172128
- Product code
- PIE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-11-22
- Date received
- 2017-07-14
- Regulation
- 876.5980
- Classification name
- Esophageal Dilator With Balloon And Electrode Sensors
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- John O’Dea
- Address
- Galway Business Park Dangan Galway IE
FDA Registration Numbers#
- 9681384
- 3004904811
- 3018094310
Source Documents#
Other 510(k) Records For Product Code PIE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142000 | ESOFLIP ES | Crospon, Ltd. | 2014-09-25 |
Legacy Summary#
summary
FDA Review#
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