Name: Predicase
Price: 199 USD

K-number	K233778
Device name	Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
Applicant	Zhuhai Pusen Medical Technology Co., Ltd.
Product code	FGB
Device class	Class II
Decision date	Jul 16, 2024
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)

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