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510(k) K252021

Disposable Endoscopic Injection Needles by Changzhou New Med Micro-Medtech Co., Ltd. — Product Code FBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2025
Date Received
June 30, 2025
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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