Integra Electrode Tunneling Needle
FDA 510(k) K102802 · Integra LifeSciences Corporation
510(k) numberK102802
Submission
- Device name
- Integra Electrode Tunneling Needle
- Applicant
- Integra LifeSciences Corporation
Planisboro, NJ, US - Received
- September 27, 2010
- Decision date
- November 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GYC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…GYC · Traditional | Neuralynx, Inc. | 04/14/2025SE |
| K242618 | Layer 7-TGYC · Traditional | Precision Neuroscience, Corp. | 03/30/2025SE |
| K221123 | WISE Cortical Strip (WCS)GYC · Traditional | Wise S.R.L. | 11/22/2022SE |
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip…GYC · Traditional | Spes Medica Srl | 11/10/2022SE |
| K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)GYC · Traditional | Dixi Medical | 10/02/2021SE |
| K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)GYC · Traditional | Blackrock Microsystems | 02/14/2020SE |
| K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid…GYC · Traditional | Ad-Tech Medical Instrument Corporation | 01/25/2020SE |
| K192764 | NeuroOne Cortical ElectrodeGYC · Traditional | Neuroone, Inc. | 11/26/2019SE |
| K183437 | AirRay Subdural Cortical ElectrodesGYC · Traditional | Cortec GmbH | 03/12/2019SE |
| K180761 | SD LTM STIM Cortical StimulatorGYC · Traditional | Micromed S.P.A. | 06/18/2018SE |
More from Micromed S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 10/08/2025SE |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)GWG · Special | 04/09/2025SE |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/11/2024SE |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 07/11/2023SE |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | 08/22/2022SE |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Special | 07/15/2022SE |
| K210128 | INTEGRA Wound Matrix (Macro-Channels)KGN · Traditional | 10/08/2021SE |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…HRS · Traditional | 07/27/2021SE |
| K193346 | Codman Surgical Patties & StripsHBA · Traditional | 11/20/2020SE |
| K201507 | Cadence Total Ankle SystemHSN · Special | 06/29/2020SE |
Questions and answers
When was Integra Electrode Tunneling Needle cleared by the FDA?
Integra Electrode Tunneling Needle (K102802) received a 510(k) decision of Substantially Equivalent on November 23, 2010, 57 days after the submission was received.
What is the product code of K102802?
The FDA product code is GYC – Electrode, Cortical, a Class II (moderate risk) device regulated under 21 CFR 882.1310.