Name: Predicase
Price: 199 USD

K-number	K181127
Device name	EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control
Applicant	Interscope, Inc.
Product code	PTE
Device class	Class II
Decision date	Jan 3, 2019
Decision	Substantially Equivalent
Regulation	884.1690

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Source

View the full FDA submission: accessdata.fda.gov

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EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control

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