Name: Predicase
Price: 199 USD

K-number	K231872
Device name	Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)
Applicant	Kirwan Surgical Products, LLC
Product code	GEI
Device class	Class II
Decision date	Aug 25, 2023
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)

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