ETN · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-11-10 → 2026-02-27

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Medtronic Xomed, Inc.	4	1	2026-02-10
Inomed Medizintechnik GmbH	3	0	2025-06-13
Suzhou Haishen Medical Device Associates Co., Ltd.	1	0	2023-12-21
Retropsoas Technologies, LLC	1	0	2024-07-31
Nvision Biomedical Technologies, Inc.	1	0	2023-10-06
Allotrope Medical, Inc.	1	0	2020-11-10
Checkpoint Surgical	1	0	2021-08-26
Biosys Biyomedikal Muhendislik San. VE Tic. A.S.	1	0	2024-12-13
Epineuron Technologies, Inc.	1	1	2026-02-27

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
64553	CPT	—	Medium	CPT for percutaneous implantation of neurostimulator electrode array; cranial nerve
64561	CPT	—	Medium	CPT for percutaneous implantation of neurostimulator electrode array; peripheral nerve

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-02-27	K253536	Epineuron Technologies, Inc.	Evala Nerve Stimulator (EPNR002)
2026-02-10	K251672	Medtronic Xomed, Inc.	NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080)
2025-06-13	K242852	Inomed Medizintechnik GmbH	ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
2024-12-13	K233001	Biosys Biyomedikal Muhendislik San. VE Tic. A.S.	Bioscope Neuromonitor Device
2024-07-31	K241917	Retropsoas Technologies, LLC	EARP Nerve Cuff Electrode
2023-12-21	K232888	Suzhou Haishen Medical Device Associates Co., Ltd.	Disposable Laryngeal Electrodes
2023-10-26	K230320	Medtronic Xomed, Inc.	NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
2023-10-06	K230853	Nvision Biomedical Technologies, Inc.	EARP Nerve Cuff Electrode
2023-08-30	K231580	Medtronic Xomed, Inc.	NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
2023-01-27	K223254	Inomed Medizintechnik GmbH	C2 Xplore
2022-11-11	K212164	Inomed Medizintechnik GmbH	Mapping Suction Probe
2022-03-21	K213246	Medtronic Xomed, Inc.	NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
2021-08-26	K212355	Checkpoint Surgical	Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
2020-11-10	K200886	Allotrope Medical, Inc.	StimSite

ETN · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances