Durashield Device Kit— 510(k) K252995
Substantially EquivalentSurGenTec, LLC
FDA 510(k) clearance K252995 for Durashield Device Kit, Substantially Equivalent on 2026-09-17. Applicant: SurGenTec, LLC. Device class: 2.
Summary
Durashield Device Kit comes from SurGenTec, LLC under product code GZT (Retractor, Self-Retaining, For Neurosurgery). The record doesn't list what's in the kit.
Class II, 21 CFR 882.4800. Neurology is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
SurGenTec filed from Boca Raton, Florida. The decision came 364 calendar days after FDA received it (September 18, 2025 to September 17, 2026).
Clearance details
- Applicant
- SurGenTec, LLC
- Product code
- Product code GZT
- Device class
- Class 2
- Regulation
- 21 CFR 882.4800
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boca Raton, FL, US
Recent devices under product code GZT
view all- K210615 — Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
- K202694 — Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family)
- K202072 — MindsEye Expandable Port
- K180610 — Geister retractor for neuro - and spine surgery
- K172433 — NICO BrainPath
More clearances from SurGenTec, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.