# K252995: Durashield Device Kit

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Sep 17, 2026 after 364 days
- Product code: GZT (Retractor, Self-Retaining, For Neurosurgery)
- Device class: 2
- Regulation: 21 CFR 882.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K780706 (1978). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180610: Geister retractor for neuro - and spine surgery, Geister Medizin Technik GmbH (2018) Summary page 4.

## Indications for use
The DuraShield™ Device Kit is indicated for use as a nerve and soft tissue protector during spinal surgery in the lumbar spine. Durashield is intended to provide shielding, guarding, and retraction of the dura, nerve roots, blood vessels, and other sensitive soft tissue structures to maintain a clear surgical field during open and minimally invasive spinal procedures.

Source page: https://510kreport.com/device/K252995
Methodology: https://510kreport.com/methodology