510(k) K182895
K182895 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Wilson-Cook Achalasia Balloon". The FDA issued a decision of Substantially Equivalent on January 25, 2019. 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. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2019
- Date Received
- October 15, 2018
- Clearance Type
- Traditional
- 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.