INTEGRA ELECTRODE TUNNELING NEEDLE— 510(k) K102802
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K102802 for INTEGRA ELECTRODE TUNNELING NEEDLE, Substantially Equivalent on 2010-11-23. Applicant: Integra LifeSciences Corporation. Device class: 2.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code GYC
- Device class
- Class 2
- Regulation
- 21 CFR 882.1310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Planisboro, NJ, US
Recent devices under product code GYC
view all- K250094 — Atlas Stim Headbox (NK) (31-0601-0077) +9 more
- K242618 — Layer 7-T
- K221123 — WISE Cortical Strip (WCS)
- K211954 — Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
- K201931 — Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
More clearances from Integra LifeSciences Corporation
view all- K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K250752 — AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
- K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K221835 — CUSA Clarity Ultrasonic Surgical Aspirator System
Data sourced from openFDA. This site is unofficial and independent of the FDA.