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510(k) K220292

Disposable Endoscope Injection Needle by Yangzhou Fartley Medical Instrument Technology Co., Ltd. — Product Code FBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2022
Date Received
February 1, 2022
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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