Chrysalis Intelligence · Product Codes · GWG

GWG · Unclassified

15 clearances · 10 unique sponsors

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Device class
—
Regulation —
Total clearances
15
2020-11-04 → 2026-06-04
Last 12 months
2
Unique sponsors
10
Classification details
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
Clearmind Biomedical 3 0 2023-10-13
Rebound Therapeutics Corporation 2 0 2023-10-27
Clarus Medical, LLC 2 0 2023-11-21
Hjy Smart Medical Device Co., Ltd. 2 0 2025-05-21
Carl Zeiss Meditec, AG 1 0 2023-09-21
Stryker 1 0 2021-08-06
Integra LifeSciences Corporation 1 0 2025-04-09
Stryker Instruments 1 1 2026-05-08
Stryker Endoscopy 1 1 2026-06-04
VPIX Medical, Inc. 1 0 2024-08-21
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
31575 CPT — Medium CPT code for endoscopy procedures; neurological endoscope use in diagnostic examinations
95870 CPT — Medium CPT code for electromyography (EMG) and related neurological procedures with endoscopic assistance
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-04 K253602 Stryker Endoscopy Precision S 4K Sinuscope
2026-05-08 K253679 Stryker Instruments Hydro Irrigation System
2025-05-21 K243429 Hjy Smart Medical Device Co., Ltd. HJY VisualNext 3D Endoscopic Vision System
2025-04-09 K250752 Integra LifeSciences Corporation AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
2024-08-21 K233391 VPIX Medical, Inc. cCeLL - In vivo
2023-11-21 K223615 Clarus Medical, LLC Digital ClarusScope System, Digital NeuroPEN System
2023-10-27 K232618 Rebound Therapeutics Corporation Aurora Surgiscope System
2023-10-13 K230125 Clearmind Biomedical Neuroblade System
2023-09-21 K232159 Carl Zeiss Meditec, AG QEVO System
2023-07-28 K222735 Hjy Smart Medical Device Co., Ltd. HJY VisualNext Endoscopic Vision System
2021-08-06 K211202 Stryker 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes
2021-04-02 K210251 Clearmind Biomedical ClearPath Disposable Introducer
2021-03-18 K200925 Clarus Medical, LLC Clarus Peel-Away Introducer Sheath
2020-11-27 K201308 Clearmind Biomedical Axonpen, Axonmonitor, Axonbox, Tablet
2020-11-04 K201840 Rebound Therapeutics Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence