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510(k) K251692

Advanced Tissue Resection Device by Micro-Tech (Nanjing) Co., Ltd. — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2026
Date Received
June 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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