Compass Steerable Needle

Bronchoscope Accessory

Serpex Medical, Inc.

The following data is part of a premarket notification filed by Serpex Medical, Inc. with the FDA for Compass Steerable Needle.

Pre-market Notification Details

Device IDK221206
510k NumberK221206
Device Name:Compass Steerable Needle
ClassificationBronchoscope Accessory
Applicant Serpex Medical, Inc. 3350 Scott Blvd, Suite 37B Santa Clara,  CA  95054
ContactSasha Schrode
CorrespondentLaurie Lewandowski
Honkanen Consulting, Inc. 738 Saddle Wood Drive Eagan,  MN  55123
Product CodeKTI  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-26
Decision Date2022-08-25

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