# HHK: Curette, Suction, Endometrial (And Accessories)

- Device class: 2; regulation: 21 CFR 884.1175; FDA's rule: 510(k) required
- FDA decisions: 42
- 510(k) review time 2021–2025: median 171 days (middle half 145–198)
- Recalls: 3 (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)
- 2000: 4
- 2002: 1
- 2003: 1
- 2004: 1
- 2005: 1
- 2010: 1
- 2011: 1
- 2020: 2
- 2024: 1
- 2025: 1

## Most-cited predicates
- K881456: Pipelle DE Cornier Endometrial Suction Curette (1988), cited by 2
- K021876: Mas with or Without Syringe (2003), cited by 1
- K915491: Curelle (1992), cited by 1
- K854415: Endometrial Pipelle (1986), cited by 1
- K914220: Pioneer Pro-Pump (1992), cited by 1
- K974819: Selectcells (TM) Mini (1998), cited by 1
- K991895: Rampipella, Singe Port (720196) & Wedge-Shaped Port (720217) (1999), cited by 1
- K914241: Pioneer Pro-Pump Dual Control (1992), cited by 1
- K192534: CrossBay Endometrial Tissue Sampler (ETS) (2020), cited by 1
- K092982: The Panpac Suction Curette (2010), cited by 1

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