# GDF: Guide, Needle, Surgical

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 28
- Recalls: 12 (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)
- 1985: 1
- 1986: 3
- 1988: 1
- 1989: 3
- 1990: 2
- 1992: 4
- 1993: 3
- 1994: 4
- 1995: 2
- 2003: 1

## Most-cited predicates
- K031173: Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013 (2003), cited by 2
- K920816: Percuguide Lesion Marking (1992), cited by 1
- K900903: Kopans Hookwire Lesion Localization Needle (1990), cited by 1
- K863090: Percu Guide I (Loop Type) (1986), cited by 1
- K914941: Simon Breast Lesion Localization Needle (1992), cited by 1

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