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510(k) K252012

SPY Cystoscope/Hysteroscope by Stryker Endoscopy — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2025
Date Received
June 27, 2025
Clearance Type
Special
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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