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510(k) K254050

Manual Tissue Removal Device by Suzhou AcuVu Medical Technology Co., Ltd. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2026
Date Received
December 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

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