K132337 is an FDA 510(k) clearance for the ESOFLIP BALLOON DILATION CATHETER. This device is classified as a Esophageal Dilator Balloon With Or Without Electrode Sensors (Class II - Special Controls, product code PID).
Submitted by Crospon, Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on October 7, 2013, 73 days after receiving the submission on July 26, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980. To Dilate The Lower Esophageal Sphincter Of Patients With Achalasia..
| 510(k) Number | K132337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2013 |
| Decision Date | October 07, 2013 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PID — Esophageal Dilator Balloon With Or Without Electrode Sensors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |
| Definition | To Dilate The Lower Esophageal Sphincter Of Patients With Achalasia. |