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510(k) K232200

Disposable Injection Needles by Ningbo Xinwell Medical Technology Co., Ltd. — Product Code FBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2024
Date Received
July 25, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.

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