# K231691: Phantom XL Insulated Dilators

- Pathway: 510(k) (Special)
- Applicant: TeDan Surgical Innovations, Inc.
- Decided: Jun 29, 2023 after 20 days
- Product code: GXZ (Electrode, Needle)
- Device class: 2
- Regulation: 21 CFR 882.1350
- 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 K980148 (1998). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140088: Phantom XL Insulated Dilators, Tedan Surgical Innovations, LLC (2014) Summary page 4.

## Most influential descendants
- K253580: Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) (2026), 0 descendants of its own

## Indications for use
Phantom XL Insulated Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site, to assist in locating those nerves at risk during the surgical procedure.

Source page: https://510kreport.com/device/K231691
Methodology: https://510kreport.com/methodology