K050232 is an FDA 510(k) clearance for the RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR. This device is classified as a Esophageal Dilator Balloon With Or Without Electrode Sensors (Class II - Special Controls, product code PID).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 11, 2005, 38 days after receiving the submission on February 1, 2005.
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 | K050232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2005 |
| Decision Date | March 11, 2005 |
| Days to Decision | 38 days |
| Submission Type | Special |
| 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. |