Name: Predicase
Price: 199 USD

K-number	K252889
Device name	Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
Applicant	Olympus Medical Systems Corporation
Product code	KNS
Device class	Class II
Decision date	Nov 25, 2025
Decision	Substantially Equivalent
Regulation	876.4300

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)

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