Name: Predicase
Price: 199 USD

K-number	K232635
Device name	IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
Applicant	Boston Scientific
Product code	GEH
Device class	Class II
Decision date	Nov 22, 2023
Decision	Substantially Equivalent
Regulation	878.4350

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Source

View the full FDA submission: accessdata.fda.gov

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IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)

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