LiNA OperaScope Needle

Endoscopic Injection Needle, Gastroenterology-urology

LiNA Medical ApS

The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Lina Operascope Needle.

Pre-market Notification Details

Device IDK221085
510k NumberK221085
Device Name:LiNA OperaScope Needle
ClassificationEndoscopic Injection Needle, Gastroenterology-urology
Applicant LiNA Medical ApS Formervangen 5 Glostrup,  DK 2600
ContactJaroslaw Mrówczynski
CorrespondentScott Blood
MEDIcept, Inc. 200 Homer Avenue Ashland,  MA  01821
Product CodeFBK  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-13
Decision Date2022-09-02

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