GZL · Electrode, Depth · Chrysalis Intelligence

Device class

Class II

Regulation 882.1330

Total clearances

2020-01-02 → 2026-04-17

Last 12 months

Unique sponsors

Classification details

Medical specialty

Neurology

Review panel

Regulation number

882.1330

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
Alpha Omega Engineering , Ltd.	3	0	2025-03-30
Ice Neurosystems, Inc.	2	0	2022-12-06
Ad-Tech Medical Instrument Corporation	2	0	2023-05-18
Sensomedical Labs, Ltd.	2	1	2026-04-17
Neuroone Medical Technologies Corp.	2	0	2022-10-20
Dixi Medical	1	0	2021-11-18
Beijing Sinovation Medical Technology Co., Ltd.	1	1	2025-11-05

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.

Code	Type	Description	Confidence	Rationale
95822	CPT	—	Medium	EEG with video recording; depth electrodes used in epilepsy monitoring and brain mapping
95956	CPT	—	Medium	Monitoring for intraoperative neurophysiology; depth electrode arrays used in surgical monitoring

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-17	K253970	Sensomedical Labs, Ltd.	Wovyn Depth Electrode
2025-11-05	K250363	Beijing Sinovation Medical Technology Co., Ltd.	Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept
2025-03-30	K250601	Alpha Omega Engineering , Ltd.	Neuro Omega System; NeuroSmart System
2023-05-18	K223276	Ad-Tech Medical Instrument Corporation	Anchor Bolts as Accessories to Depth Electrodes
2023-05-18	K223269	Ad-Tech Medical Instrument Corporation	Spencer Probe Depth Electrodes
2023-04-18	K213170	Sensomedical Labs, Ltd.	SENSOSEEG Depth Electrodes
2022-12-06	K222706	Ice Neurosystems, Inc.	iCE-SG2 Subcutaneous Electrode Kit
2022-10-20	K222404	Neuroone Medical Technologies Corp.	Evo® sEEG System
2022-09-16	K220553	Alpha Omega Engineering , Ltd.	Neuro Omega System, NeuroSmart System
2021-11-18	K202087	Dixi Medical	DIXI Medical Microdeep Micro-Macro Depth Electrodes
2021-09-01	K211367	Neuroone Medical Technologies Corp.	Evo sEEG System
2021-03-08	K201678	Ice Neurosystems, Inc.	iCE-SG Subcutaneous Electrode Arrays
2020-01-02	K191739	Alpha Omega Engineering , Ltd.	Sterile LeadConfirm