# K060563: Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV

- Pathway: 510(k) (Traditional)
- Applicant: Pajunk GmbH
- Decided: Jun 2, 2006 after 114 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). 22 ancestors in all.
1 later device descends from it; 1 cites 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)
- K043130: Modification to Pajunk Stimulong Plus Catheter Sets, Pajunk GmbH (2004) Summary page 1.
- K033018: Stimulong Plus Catheter Set Model, Various, Pajunk GmbH (2004) Summary page 1.
- K042979: Modification to: Plexalong Sets, Pajunk GmbH (2004) Summary page 1.
- K023218: Modification to Plexolong Sets, Pajunk GmbH (2003) Summary page 1.
- K013041: Plexolong Sets, Pajunk GmbH (2002) Summary page 1.
- K040965: Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles, Pajunk GmbH (2004) Summary page 1.
- K911202: Atraumatic Standard Sprotte Needle, Pajunk GmbH (1992) Summary page 1.
- K911260: Atraumatic Standard Sprotte Needle, Pajunk GmbH (1991) Summary page 1.
- K911221: Atraumatic Special Sprotte Needle, Pajunk GmbH (1992) Summary page 1.
- K932400: Espocan Combined Spinal/Epidural Needle Set & Tray, B. Braun of America, Inc. (1993) Summary page 1.
- K813186: Perfix Set for Epidural Anesthesia W/Tuo, Burron Medical Products, Inc. (1981) Summary page 1.

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

## Indications for use
The Pajunk Loss of Resistance (LOR)-Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration. The Pajunk Fixolong is an adhesive disk with catheter clips and flat filter attachment point on top. It is employed for fixing the catheter during long term anesthesia conduction. The adhesive is hypo-allergenic and prevents accidental removal of epidural catheter. The catheter fastening clips allows stabilization of epidural catheter and prevents accidental movement. On the top there is an attachment site for flat filter to protect fixation The Pajunk anesthesia conduction flat filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid. The Pajunk Tuohy Borst Adaptor is connected to the needle via Luer connector. It ensures sealing and fixation of the catheter end and allows attachment of a Luer Lock syringe or infusion device. The Pajunk EpiSpin anesthesia conduction kit is indicated for administration of regional Combined Spinal-Epidural (CSE) anesthesia. The anesthesia conduction needle is intended for transient delivery of anesthetics to the spinal and epidural space, as well as catheter placement into the epidural space to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours). The Pajunk catheter is placed in the epidural space to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours).

Source page: https://510kreport.com/device/K060563
Methodology: https://510kreport.com/methodology