# K082183: Pajunk's Generic Convenience Tray for Regional Anesthesia: CSF

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Oct 28, 2008 after 88 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: 6 generations back to K840287 (1984). 25 ancestors in all.
No later device cites it as a predicate yet.
3 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060311: Epilong Kit for Anesthesiology, PAJUNK GmbH Medizintechnologie (2006) Summary page 1.
- K060563: Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV, Pajunk GmbH (2006). Our reading of the summary gave K060663, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “EpiSpin”. Summary page 2.
- K062900: Pajunks Stimulong Tsui-Method Set, PAJUNK GmbH Medizintechnologie (2007) Summary page 1.

## Indications for use
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Epidural single shot is intended for the administration of regional anaesthesia to the epidural space employing single-shot technique also including optional localization via electrical stimulus. Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: CSF is intended for the administration of spinal, epidural or combined spinal-epidural regional anaesthesia, single-shot or continuous technique, optional localization via electrical stimulus. Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Spinal single shot is intended for the administration of regional anaesthesia to the spinal space employing single-shot technique also including optional localization via electrical stimulus. Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Epidural continuous is intended for the administration of regional anaesthesia to the epidural space employing continuous technique also including optional localization via electrical stimulus. Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Spinal continuous is intended for the administration of regional anaesthesia to the epidural space employing continuous technique also including optional localization via electrical stimulus. Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: CSE is intended for the administration of anaesthesia via CSE-technique, single-shot/ continuous technique, optional localization via electrical stimulus. Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure supply is intended to support the administration of spinal, epidural and CSE-technique applied anaethesia, single-shot/ continuous technique, optional localization via electrical stimulus regional anaethesia. Neither needle nor catheter is included.

Source page: https://510kreport.com/device/K082183
Methodology: https://510kreport.com/methodology