Chrysalis Intelligence · Product Codes · GYC

GYC · Unclassified

7 clearances · 7 unique sponsors

Device class
Regulation —
Total clearances
7
2020-01-25 → 2025-04-14
Last 12 months
0
Unique sponsors
7
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Neuralynx, Inc. 1 0 2025-04-14
Ad-Tech Medical Instrument Corporation 1 0 2020-01-25
Dixi Medical 1 0 2021-10-02
Precision Neuroscience, Corp. 1 0 2025-03-30
Wise S.R.L. 1 0 2022-11-22
Blackrock Microsystems 1 0 2020-02-14
Spes Medica Srl 1 0 2022-11-10
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
95822 CPT Medium EEG with video recording; cortical electrodes used in intraoperative monitoring and epilepsy mapping
95956 CPT Medium Monitoring for intraoperative neurophysiology; cortical electrode array used during neurosurgery
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-04-14 K250094 Neuralynx, Inc. Atlas 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)
2025-03-30 K242618 Precision Neuroscience, Corp. Layer 7-T
2022-11-22 K221123 Wise S.R.L. WISE Cortical Strip (WCS)
2022-11-10 K211954 Spes Medica Srl Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
2021-10-02 K201931 Dixi Medical Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
2020-02-14 K191346 Blackrock Microsystems Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
2020-01-25 K191186 Ad-Tech Medical Instrument Corporation Subdural 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 Electrode