ClearPath Disposable Introducer

Endoscope, Neurological

ClearMind Biomedical

The following data is part of a premarket notification filed by Clearmind Biomedical with the FDA for Clearpath Disposable Introducer.

Pre-market Notification Details

Device IDK210251
510k NumberK210251
Device Name:ClearPath Disposable Introducer
ClassificationEndoscope, Neurological
Applicant ClearMind Biomedical 5F, No. 167, Fuxing N. Rd., Songshan Dist. Taipei,  TW 105403
ContactSheng-chi (aka Vance Lin) Lin
CorrespondentCraig Coombs
Coombs Medical Device Consulting, Inc. 1100 Pacific Marina, Suite 806 Alameda,  CA  94501
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-29
Decision Date2021-04-02

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