# K181544: Anchor Bolt (as an accessory to Depth Electrodes)

- Pathway: 510(k) (Traditional)
- Applicant: Ad-Tech Medical Instrument Corporation
- Decided: Aug 9, 2018 after 58 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K802151 (1980). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970418: PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX), Pmt Corp. (1997) Summary page 4.

## Most influential descendants
- K223276: Anchor Bolts as Accessories to Depth Electrodes (2023), 0 descendants of its own

## Recalls of this device
- Jun 18, 2019 · Class II · Z-2204-2019: On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 and May 31, 2019 Ad-Tech personnel have distributed non-sterile anchor bolt parts to one independent rep
- Jun 18, 2019 · Class II · Z-2408-2019: Supplemental information provided with devices may indicate that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved

## Indications for use
The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.

Source page: https://510kreport.com/device/K181544
Methodology: https://510kreport.com/methodology