SAM IO Intraosseous Access System

Needle, Hypodermic, Single Lumen

SAM® Medical Products, Inc.

The following data is part of a premarket notification filed by Sam® Medical Products, Inc. with the FDA for Sam Io Intraosseous Access System.

Pre-market Notification Details

Device IDK191488
510k NumberK191488
Device Name:SAM IO Intraosseous Access System
ClassificationNeedle, Hypodermic, Single Lumen
Applicant SAM® Medical Products, Inc. 27350 SW 95th Ave, Suite 3038 Wilsonville,  OR  97070
ContactJeff Lipps
CorrespondentMichelle Lott
Lean RAQA, LLC 12602 North Summerwind Drive Marana,  AZ  85658
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-04
Decision Date2019-11-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20822045000289 K191488 000
30822045000293 K191488 000
20822045000272 K191488 000
10822045000329 K191488 000
20822045000296 K191488 000
10822045000282 K191488 000
00822045000278 K191488 000
10822045000244 K191488 000
00850056748018 K191488 000

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