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510(k) K182895

Wilson-Cook Achalasia Balloon by Wilson-Cook Medical, Inc. — Product Code PID

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.

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Other clearances for product code PID

  • K132337 — ESOFLIP BALLOON DILATION CATHETER (October 7, 2013)
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