510(k) K050232
K050232 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR". The FDA issued a decision of Substantially Equivalent on March 11, 2005. The device falls under product code PID (Esophageal Dilator Balloon With Or Without Electrode Sensors), a Class II device regulated under 21 CFR 876.5980. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2005
- Date Received
- February 1, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esophageal Dilator Balloon With Or Without Electrode Sensors
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
To dilate the lower esophageal sphincter of patients with Achalasia.