# HIH: Hysteroscope (And Accessories)

- Device class: 2; regulation: 21 CFR 884.1690; FDA's rule: 510(k) required
- FDA decisions: 175
- 510(k) review time 2021–2025: median 155 days (middle half 93–241)
- Recalls: 7 (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)
- 2017: 2
- 2018: 8
- 2019: 14
- 2020: 7
- 2021: 4
- 2022: 2
- 2023: 4
- 2024: 6
- 2025: 3
- 2026: 7

## Most-cited predicates
- K040390: Stryker Urology and Gynecology Hardware System (2004), cited by 7
- K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories (2015), cited by 5
- K132384: U-Scope 8000 System with HSC+Emb Cannula (2014), cited by 5
- K100559: Myosure Hysteroscopic Tissue Removal System (2010), cited by 5
- K880314: Hysteroscope Autonom 4992 (1988), cited by 5
- K013870: Smith & Nephew Operative Hysteroscope, Model 7209208; Smith & Nephew Continuous Flow Sheath, Model 8105224 (2002), cited by 4
- K132015: Truclear Morcellation System and Truclear Morcellators (2013), cited by 4
- K031787: Smith & Nephew Iur Morcellation System (2003), cited by 4
- K980302: Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes (1998), cited by 4
- K961688: Microspan Hysteroscope (1996), cited by 4

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