# K202699: E-Cath STIM acc. Tsui

- Pathway: 510(k) (Special)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Dec 29, 2020 after 104 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: 7 generations back to K813186 (1981). 20 ancestors in all.
No later device cites it as a predicate yet.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152952: E-Cath, PAJUNK GmbH Medizintechnologie (2016) Summary page 5.
- K033018: Stimulong Plus Catheter Set Model, Various, Pajunk GmbH (2004) Summary page 5.

## Indications for use
The E-Cath STIM acc. Tsui System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle. After needle removal, to assist the physician pinpoint conduction catheter placement, an electrical stimulus can be applied to the conduction catheter tip via the catheter adapter. The E-Cath STIM acc. Tsui System is contraindicated for the epidural space.

Source page: https://510kreport.com/device/K202699
Methodology: https://510kreport.com/methodology