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510(k) K233240

GERDX-System by G-Surg GmbH — Product Code ODE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2024
Date Received
September 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.

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