# GWG: Endoscope, Neurological

- Device class: 2; regulation: 21 CFR 882.1480; FDA's rule: 510(k) required
- FDA decisions: 95
- 510(k) review time 2021–2025: median 197 days (middle half 63–323)
- Recalls: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 2
- 2017: 4
- 2018: 4
- 2019: 3
- 2020: 2
- 2021: 3
- 2023: 5
- 2024: 1
- 2025: 2
- 2026: 4

## Most-cited predicates
- K211202: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes (2021), cited by 5
- K180146: KARL STORZ ICG Imaging System (2018), cited by 4
- K971340: Olympus Neuro Endoscope (1998), cited by 3
- K983365: Aesculap Minop System (1998), cited by 3
- K131434: VS3 Stereoscopic High Definition Vision System (2013), cited by 3
- K081102: Vsu - Visionsense Stereoscopic Vision System (2008), cited by 3
- K201840: Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) (2020), cited by 2
- K002572: Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 (2000), cited by 2
- K072410: Ksea Clearvision II, Model 40334120 (2008), cited by 2
- K990333: Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015 (1999), cited by 2

Source page: https://510kreport.com/product-code/GWG
Data by year (CSV): https://510kreport.com/product-code/GWG.csv