510(k) clearance
Durashield Device Kit
- 510(k) number
- K252995
- Applicant
- SurGenTec, LLC
- Decision date
- Sep 17, 2026
- Date received
- Sep 18, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GZT
- Device type
- Retractor, Self-Retaining, For Neurosurgery
- Device class
- Class II
- Regulation
- 21 CFR 882.4800
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Boca Raton, FL, US