Durashield Device Kit
SurGenTec, LLC · Neurology
Open FDA's page for this record- Third party flag
- N
- City
- Boca Raton
- Advisory committee description
- Neurology
- Address 1
- 911 Clint Moore Rd.
- Statement or summary
- Summary
- Product code
- GZT
- Zip code
- 33487
- Applicant
- SurGenTec, LLC
- Decision date
- 2026-09-17
- Decision code
- SESE
- Country code
- US
- Device name
- Durashield Device Kit
- Advisory committee
- NE
- Contact
- Richard Sharp
- K number
- K252995
- State
- FL
- Date received
- 2025-09-18
- Review advisory committee
- NE
- Postal code
- 33487
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Retractor, Self-Retaining, For Neurosurgery
- Medical specialty description
- Neurology
- Regulation number
- 882.4800
- Device class
- 2
- Registration number
- 1417592, 3011547624, 1450428, 1834331, 8010422, 2029275, 3010041511, 9611274, 1528646, 3012995405, 3008110533, 1836161, 1056350, 3015967359, 1526439, 9710524, 2032098, 2133928, 2183671, 3009420598, 8030607, 8010697, 3000270450, 3010202439, 9610612, 2183946, 1526531, 1218882, 3005528784, 9680242, 9680519, 3011137372, 3010687973, 3005880844, 8040233, 2916714, 2133810, 3008864603, 3004464325, 3007648354 +40 more
- FEI number
- 3002806315, 1417592, 3011547624, 1450428, 3008238512, 1000116116, 3010041511, 3003944071, 3012995405, 3008110533, 3001644153, 3006509795, 3015967359, 1000136451, 1526439, 1000120916, 1000221916, 1000306303, 3002287318, 3002631673, 2183671, 3007475226, 3009420598, 3000270450, 1000115048, 1526531, 1218882, 3005528784, 1000140363, 3008782585, 3002902165, 3010687973, 3000717687, 3005880844, 2916714, 5870, 3008864603, 3004464325, 3010034765, 3007648354 +40 more