K-number	K233635
Device name	SPY Cystoscope/Hysteroscope
Applicant	Stryker Endoscopy
Product code	HIH
Device class	Class II
Decision date	Feb 12, 2024
Decision	Substantially Equivalent
Regulation	884.1690

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Source

View the full FDA submission: accessdata.fda.gov

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SPY Cystoscope/Hysteroscope

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