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510(k) K211227

HTx Disposable Hysteroscope System by Acuvu, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2021
Date Received
April 23, 2021
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

Other clearances by Acuvu, Inc.

  • K180096 — GDT-1000 System (April 16, 2018)

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