# HDC: Tenaculum, Uterine

- Device class: 2; regulation: 21 CFR 884.4530; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 132 days (middle half 83–182)
- Recalls: 8 (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)
- 1999: 1
- 2000: 1
- 2003: 1
- 2004: 1
- 2006: 1
- 2007: 2
- 2008: 1
- 2014: 1
- 2021: 1
- 2023: 1

## Most-cited predicates
- K992071: Transvaginal Ultrasound Probe Holder Device (1999), cited by 2
- K030078: Burbank Tenaculum, Model 09-0011-01 (2003), cited by 1
- K890379: Uterine Tentaculum (1989), cited by 1
- K930037: Atraumatic Tenacula (1994), cited by 1
- K980247: Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum (1998), cited by 1
- K891349: Campion Cervical Hook (1989), cited by 1
- K073182: Gyn Disposables Tenaculum 356T (2007), cited by 1
- K203820: ASPIVIX  v1.1 Cervical Suction Tenaculum (2021), cited by 1
- K891033: Atraumatic Tenacula (1989), cited by 1

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