# K063380: Echostim Facet Tip

- Pathway: 510(k) (Traditional)
- Applicant: Havel'S, Inc.
- Decided: Apr 25, 2007 after 168 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 K840287 (1984). 3 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K100241: Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680 (2010), 7 descendants of its own
- K173763: iovera system (2018), 2 descendants of its own
- K121846: Contiplex C Continuous Peripheral Nerve Block Needle (2012), 2 descendants of its own
- K220656: iovera System (2022), 1 descendant of its own
- K093209: Focus ( TM) Echogenic Nerve Stimulating Needle (2010), 1 descendant of its own

## Indications for use
Havel's electrically insulated anesthesia conduction needles are used to puncture the tissue in order to gain entry and locally inject anesthetics to induce regional anesthesia. An electrical stimulus may be applied to the needle via a cable and connector to assist the physician to pinpoint the area of application.

Source page: https://510kreport.com/device/K063380
Methodology: https://510kreport.com/methodology