# PGW: Ear, Nose, And Throat Stereotaxic Instrument

- Device class: 2; regulation: 21 CFR 882.4560; FDA's rule: 510(k) required
- FDA decisions: 38
- 510(k) review time 2021–2025: median 97 days (middle half 84–127)
- Recalls: 6 (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: 9
- 2017: 4
- 2018: 2
- 2019: 1
- 2020: 8
- 2021: 1
- 2022: 2
- 2023: 2
- 2025: 1
- 2026: 3

## Most-cited predicates
- K133573: Fiagon Navigation System (2014), cited by 8
- K141456: The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell (2014), cited by 6
- K161491: Scopis Hybrid Navigation System EM (2017), cited by 3
- K141551: Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved 90 (Degrees) (2014), cited by 2
- K150473: FlexPointer 1.5 mm (2015), cited by 2
- K161697: Acclarent NavWire Sinus Navigation Guidewire (2016), cited by 2
- K171661: Scopis Extended Instrument Set EM (2017), cited by 2
- K161555: KARL STORZ NAV1 Electromagnetic Navigation System (2016), cited by 2
- K200723: StealthStation FlexENT  (9736242), StealthStation S8 ENT Software (9735762) (2020), cited by 2
- K162176: Fiagon Navigation System (2016), cited by 2

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