Name: Predicase
Price: 199 USD

K-number	K213818
Device name	VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
Applicant	Covidien
Product code	GCJ
Device class	Class II
Decision date	Jun 27, 2022
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula

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