# K042979: Modification to: Plexalong Sets

- Pathway: 510(k) (Special)
- Applicant: Pajunk GmbH
- Decided: Dec 21, 2004 after 53 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K840287 (1984). 4 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013041: Plexolong Sets, Pajunk GmbH (2002) Summary page 1.
- K000722: Unipolar Needles, Pajunk GmbH (2000) Summary page 1.
- K023218: Modification to Plexolong Sets, Pajunk GmbH (2003) Summary page 1.

## Most influential descendants
- K053283: Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set (2006), 2 descendants of its own
- K060563: Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV (2006), 1 descendant of its own
- K173110: Graftsite (2018), 0 descendants of its own
- 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 Plexalong Sets are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connectors to assist the physician pinpoint the area of application. Warning: The Pajunk GmbH needles and puncture sets are not intended for RF ablation or any other type of ablation procedure

Source page: https://510kreport.com/device/K042979
Methodology: https://510kreport.com/methodology