# FCG: Biopsy Needle

- Device class: 2; regulation: 21 CFR 876.1075; FDA's rule: 510(k) required
- FDA decisions: 133
- 510(k) review time 2021–2025: median 97 days (middle half 71–265)
- Recalls: 37 (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)
- 2015: 4
- 2016: 3
- 2017: 3
- 2018: 6
- 2020: 1
- 2021: 1
- 2022: 2
- 2023: 4
- 2024: 1
- 2025: 2

## Most-cited predicates
- K083330: Echotip Ultra Ultrasound Needle (2009), cited by 9
- K934356: Wilson-Cook GI Aspiration Needle (1994), cited by 6
- K050503: Single Use Aspiration Needle NA-201SX-4022 (2005), cited by 6
- K936194: Coaxial Biopsy Needle (1994), cited by 4
- K023272: Disposable Aspiration Needle NA-200H (2002), cited by 4
- K070129: Sonotip II Ultrasound Needle System (2007), cited by 4
- K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A (2009), cited by 4
- K051247: Sonotip II Ultrasound Needle System (2005), cited by 3
- K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (2016), cited by 3
- K051506: Mielo-Can, Best-Lisas, Ben - Bone Biopsy.  Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue Biopsy (2005), cited by 3

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