ESOFLIP BALLOON DILATION CATHETER
FDA 510(k) clearance K132337 · decided 2013-10-07
Clearance details
- K-number
- K132337
- Device name
- ESOFLIP BALLOON DILATION CATHETER
- Applicant
- Crospon, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-07-26
- Decision date
- 2013-10-07
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- PID
- 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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| Wilson-Cook Achalasia Balloon (K182895) | Wilson-Cook Medical, Inc. | 2019-01-25 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only recall (Z-2038-2024) | Covidien, LLC | 2024-06-07 |