FDA.reportPublic FDA data

510(k) K243682

Device
SonoPlex STIM; SonoPlex II
Applicant
PAJUNK GmbH Medizintechnologie
510(k) number
K243682
Product code
BSP
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-27
Date received
2024-11-29
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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K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie2024-11-22
K241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie2024-09-11
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K191290Ancora Nerve Block Catheter SetAncora Medical Technology2020-02-06
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