FDA.reportPublic FDA data

510(k) K243525

Device
SonoTAP and SonoTAP II
Applicant
PAJUNK GmbH Medizintechnologie
510(k) number
K243525
Product code
BSP
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-24
Date received
2024-11-14
Regulation
868.5150
Classification name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Christian Quass
Address
Karl-Hall-Str. 1 Pajunkstr. 1 Geisingen DE 78187 78187

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BSP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243690SonoMSKPAJUNK GmbH Medizintechnologie2025-07-01
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K212328DiscCath Needle SetDisccath, LLC2021-09-26
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K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.2020-05-27
K191290Ancora Nerve Block Catheter SetAncora Medical Technology2020-02-06
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