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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K221085
Device Name LiNA OperaScope Needle
Applicant
Lina Medical Aps
Formervangen 5
Glostrup,  DK 2600
Applicant Contact Jaroslaw Mrówczynski
Correspondent
MEDIcept, Inc.
200 Homer Ave.
Ashland,  MA  01821
Correspondent Contact Scott Blood
Regulation Number876.1500
Classification Product Code
FBK  
Subsequent Product Code
HIH  
Date Received04/13/2022
Decision Date 09/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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