Decision Date2022-11-22
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
WISE Cortical Strip (WCS) is the device name listed in this FDA 510(k) record. The listed applicant is Wise S.R.L.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K221123. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the WISE Cortical Strip (WCS)?
WISE Cortical Strip (WCS) is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Wise S.R.L.. The 510(k) number is K221123.
When did WISE Cortical Strip (WCS) receive FDA 510(k) clearance?
WISE Cortical Strip (WCS) received FDA 510(k) clearance on 2022-11-22, under 510(k) number K221123.
Who is the listed applicant for WISE Cortical Strip (WCS)?
The FDA 510(k) record lists Wise S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for WISE Cortical Strip (WCS)?
The FDA product code for WISE Cortical Strip (WCS) is GYC.
Related Devices (Code: GYC)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)Neuralynx, Inc.K242618Layer 7-TPrecision Neuroscience, Corp.K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping GridSpes Medica SrlK201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)Dixi MedicalK191346Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)Blackrock MicrosystemsK191186Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural ElectrodeAd-Tech Medical Instrument Corporation
Official Source
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