K182895 is an FDA 510(k) clearance for the Wilson-Cook Achalasia Balloon. This device is classified as a Esophageal Dilator Balloon With Or Without Electrode Sensors (Class II - Special Controls, product code PID).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 25, 2019, 102 days after receiving the submission on October 15, 2018.
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 | K182895 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2018 |
| Decision Date | January 25, 2019 |
| Days to Decision | 102 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. |