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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)
510(k) Number K241953
Device Name SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
Applicant
PAJUNK GmbH Medizintechnologie
Karl-Hall-Str. 1
Pajunkstr. 1
Geisingen,  DE 78187
Applicant Contact Christian Quass
Correspondent
PAJUNK GmbH Medizintechnologie
Karl-Hall-Str. 1
Pajunkstr. 1
Geisingen,  DE 78187
Correspondent Contact Chiara Meyer
Regulation Number868.5150
Classification Product Code
BSP  
Date Received07/03/2024
Decision Date 11/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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