# HEE: Set, Anesthesia, Paracervical

- Device class: 2; regulation: 21 CFR 884.5100; FDA's rule: 510(k) required
- FDA decisions: 9
- 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)
- 1991: 2
- 1996: 1
- 1997: 1
- 1998: 1
- 1999: 1
- 2000: 1
- 2002: 1
- 2005: 1

## Most-cited predicates
- K910252: Potocky Neddle (TM) Disposable Injection Needle (1991), cited by 3
- K973671: Endocervical Block Needle (1997), cited by 1
- K021224: Endocervical Block Needle (2002), cited by 1
- K000117: Avid-Nit Cervical Regional Anesthesia Needle (2000), cited by 1

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