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Pajunk Medical Systems: FDA-registered device maker in Alpharetta, GA, United States, 3 510(k) clearances

Name: Pajunk Medical Systems FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Pajunk Medical Systems is registered with the FDA (registration 3004076349) in Alpharetta, GA, United States. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 1, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004076349
Address: 4575 Marconi Dr., Alpharetta, GA, United States, 30005
Owner or operator: PAJUNK GmbH Medizintechnologie (8010639)
Roles: Complaint file establishment, Repackager or relabeler
First device listed: October 24, 2016
Registered through: 2026
Brand names listed: EpiLong Soft NRFit, Epidural anesthesia kit, Injection tube, anesthetic agent, Nerve Block Tray, SPROTTE NRFit Kit, SPROTTE® NRFit kit, Sono MSK, SonoBlock and more

Devices it lists

Device	Product code	Class	Role	Source
Custom Anesthesia Tray	OGD	2	Repackager or relabeler	accessdata.fda.gov
Device, Biofeedback	HCC	2	Complaint file establishment	accessdata.fda.gov
Epidural Anesthesia Kit	OGE	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Repackager or relabeler	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Repackager or relabeler	accessdata.fda.gov
Nerve Block Tray	OGJ	2	Repackager or relabeler	accessdata.fda.gov
Spinal Anesthesia Kit	OFU	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 1, 2025	K243690	SonoMSK	BSP	Substantially Equivalent	PAJUNK GmbH Medizintechnologie	accessdata.fda.gov
September 11, 2024	K241954	SonoBlock; SonoBlock II	BSP	Substantially Equivalent	PAJUNK GmbH Medizintechnologie	accessdata.fda.gov
November 24, 2023	K230701	Stim2Go	IPF	Substantially Equivalent	PAJUNK GmbH Medizintechnologie	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 10, 2022	91037	Class II	Terminated	PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5	The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.	accessdata.fda.gov

Compare with other makers

Updated July 1, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.