# K243682: SonoPlex STIM; SonoPlex II

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Jun 27, 2025 after 210 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: 2 generations back to K111374 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241954: SonoBlock; SonoBlock II, PAJUNK GmbH Medizintechnologie (2024) Summary page 7.

## Indications for use
SonoPlex STIM and SonoPlex Il Needles equipped with Cornerstone reflectors are used to puncture the tissue in order to gain entry and inject local anesthetics to induce regional anesthesia. An electrical stimulus may be applied to the needle via a cable and connector to assist the physician pinpoint the area of application.

Source page: https://510kreport.com/device/K243682
Methodology: https://510kreport.com/methodology