Chrysalis Intelligence · Product Codes · GXD

GXD · Generator, Lesion, Radiofrequency

Neurology · 8 clearances · 6 unique sponsors

Device class
Class II
Regulation 882.4400
Total clearances
8
2020-02-21 → 2025-08-07
Last 12 months
0
Unique sponsors
6
Medical specialty
Neurology
Review panel
NE
Regulation number
882.4400
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
ABBOTT MEDICAL 2 0 2022-01-21
Avanos Medical, Inc. 2 0 2024-08-14
Neuroone Medical Technologies Corp. 1 0 2023-12-06
Boston Scientific Neuromodulation Corporation 1 0 2025-08-07
Epimed International 1 0 2024-05-24
Rf Innovations, Inc. 1 0 2023-03-15
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
64645 CPT Medium Lesion destruction by neurolytic agent injection; radiofrequency lesioning often paired with similar neurolytic codes
64999 CPT Low Unlisted procedure, nervous system; fallback for non-standard radiofrequency generator use
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-08-07 K251247 Boston Scientific Neuromodulation Corporation GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
2024-08-14 K242057 Avanos Medical, Inc. COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
2024-05-24 K232632 Epimed International Racz Neurostat RF Generator
2023-12-06 K231675 Neuroone Medical Technologies Corp. OneRF Ablation System
2023-03-15 K220122 Rf Innovations, Inc. APEX 6
2022-01-21 K203293 ABBOTT MEDICAL Abbott Medical Grounding Pad, model RF-DGP-IS
2020-10-21 K201610 ABBOTT MEDICAL IonicRF Generator
2020-02-21 K192491 Avanos Medical, Inc. Coolief Radiofrequency Generator (CRG) System