GWG

Endoscope, Neurological

Product code
GWG
Device name
Endoscope, Neurological
Device class
Class 2
21 CFR
21 CFR 882.1480
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
93

FDA classification definition

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (9)

Last three years. Most recent: 2026-06-04.

NumberDecision dateApplicantDevice nameSummary
K2536022026-06-04Stryker EndoscopyPrecision S 4K SinuscopePDF
K2536792026-05-08Stryker InstrumentsHydro Irrigation SystemPDF
K2434292025-05-21Hjy Smart Medical Device Co., Ltd.HJY VisualNext 3D Endoscopic Vision SystemPDF
K2507522025-04-09Integra LifeSciences CorporationAURORA® Surgiscope® System (ASX15/60); AURORA® SurgiPDF
K2333912024-08-21VPIX Medical, Inc.cCeLL - In vivoPDF
K2236152023-11-21Clarus Medical, LLCDigital ClarusScope System, Digital NeuroPEN SystemPDF
K2326182023-10-27Rebound Therapeutics CorporationAurora Surgiscope SystemPDF
K2301252023-10-13Clearmind BiomedicalNeuroblade SystemPDF
K2321592023-09-21Carl Zeiss Meditec, AGQEVO SystemPDF

9 summaries are archived here for direct download.

Official FDA classification page: GWG
Classification and pathway per current FDA publications. Data from openFDA (CC0).