# HEW: Culdoscope (And Accessories)

- Device class: 2; regulation: 21 CFR 884.1640; FDA's rule: 510(k) required
- FDA decisions: 18
- 510(k) review time 2021–2025: median 367 days (middle half 367–367)
- Recalls: 1 (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)
- 2004: 1
- 2005: 2
- 2011: 1
- 2012: 1
- 2015: 2
- 2016: 1
- 2018: 1
- 2019: 1
- 2020: 1
- 2025: 1

## Most-cited predicates
- K954311: Koh Colpotomizer System (1996), cited by 6
- K180429: Advincula Delineator Uterine Manipulator (2018), cited by 1
- K143308: GelPOINT Transvaginal Access Platform (2015), cited by 1
- K143650: CooperSurgical Advincula Delineator Uterine Manipulator (2015), cited by 1
- K980972: Rigid Culdoscope and Accessories (1998), cited by 1
- K110819: Singhmed Roolip Manipulator (2011), cited by 1
- K191294: Transvaginal Access Platform (2019), cited by 1
- K051594: Mccartney Access Tube (2005), cited by 1

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