WISE Cortical Strip (WCS)
FDA 510(k) K221123 · Wise S.R.L.
510(k) numberK221123
Submission
- Device name
- WISE Cortical Strip (WCS)
- Applicant
- Wise S.R.L.
Cologno Monzese, IT - Received
- April 18, 2022
- Decision date
- November 22, 2022
- 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 |
| 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 |
| K173684 | g.Estim PROGYC · Traditional | G.Tec Medical Engineering GmbH | 05/04/2018SE |
Questions and answers
When was WISE Cortical Strip (WCS) cleared by the FDA?
WISE Cortical Strip (WCS) (K221123) received a 510(k) decision of Substantially Equivalent on November 22, 2022, 218 days after the submission was received.
What is the product code of K221123?
The FDA product code is GYC – Electrode, Cortical, a Class II (moderate risk) device regulated under 21 CFR 882.1310.