Name: Predicase
Price: 199 USD

K-number	K231725
Device name	Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
Applicant	Hunan Endoso Life Technology Co., Ltd.
Product code	GCJ
Device class	Class II
Decision date	Oct 16, 2023
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)

Everything you need for a 510(k) submission. Nothing you don't.