# FDS: Gastroscope And Accessories, Flexible/Rigid

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 79
- 510(k) review time 2021–2025: median 185 days (middle half 83–234)
- 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)
- 2017: 1
- 2018: 6
- 2019: 5
- 2020: 2
- 2021: 5
- 2022: 2
- 2023: 3
- 2024: 5
- 2025: 8
- 2026: 7

## Most-cited predicates
- K172916: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (2018), cited by 11
- K131902: Pentax Video Upper G.I. Scopes (EG Family) (2014), cited by 8
- K984358: Olympus Distal Attachment, Models MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 (1999), cited by 7
- K162749: FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR (2017), cited by 5
- K971660: Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary Equipment (1997), cited by 4
- K210162: Endoscope Model EI-740D/S (2021), cited by 3
- K011151: Evis Exera Gastrointestinal Videoscope Gif-Q160Z (2001), cited by 3
- K063316: Fujinon Model EG-530N Trans Nasal Insertion (2007), cited by 3
- K042043: Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5 (2004), cited by 3
- K213606: EvoEndo Single-Use Endoscopy System (2022), cited by 2

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