# K062900: Pajunks Stimulong Tsui-Method Set

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Jan 12, 2007 after 107 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K840287 (1984). 21 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033018: Stimulong Plus Catheter Set Model, Various, Pajunk GmbH (2004) Summary page 1.
- K043130: Modification to Pajunk Stimulong Plus Catheter Sets, Pajunk GmbH (2004) Summary page 1.
- K000722: Unipolar Needles, Pajunk GmbH (2000) Summary page 3.
- K040965: Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles, Pajunk GmbH (2004) Summary page 3.
- K060311: Epilong Kit for Anesthesiology, PAJUNK GmbH Medizintechnologie (2006) Summary page 1.

## Most influential descendants
- K082183: Pajunk's Generic Convenience Tray for Regional Anesthesia: CSF (2008), 0 descendants of its own
- K082164: Pajunk's Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus: Single Shot (2008), 0 descendants of its own

## Indications for use
The Pajunk StimuLong Tsui-Method Sets are intended for delivery of continuous conduction anesthesia to epidural space as well as optional to peripheral nerves and plexus. The catheter has to be removed or replaced after 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician to precisely and safe pinpoint the area of application in peripheral use an electrical stimulus can be applied to the conduction needle. After placement of the conduction catheter in epidural space or peripheral an electrical stimulus can be applied to its tip via the catheter adapter. The set is to be used with adults and in pediatrics. The Pajunk epidural (optional: peripheral) stimulation catheter is placed inthe epidural space (otional: peripheral) to precisely identify the target area and to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours. The Pajunk epidural stimulation catheter is placed in the epidural space to precisely identify the target area and to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours. The Pajunk peripheral stimulation catheter is placed peripheral to precisely identify the target area and to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours. Pajunks Stimulation Adapter and Adapter cables are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and stimulation, for example StimuLong and StimuLong Tsui-Method. Pajunks injection valve and injection hose are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and optional stimulation, for example StimuLong and StimuLong Tsui-Method. Pajunks peripheral NanoLine-coated cannulas are accessories to Pajunks sets for peripheral anesthesia conduction and stimulation, for example StimuLong and StimuLong Tsui-Method.

Source page: https://510kreport.com/device/K062900
Methodology: https://510kreport.com/methodology