# BWH: Forceps, Biopsy, Bronchoscope (Non-Rigid)

- Device class: 2; regulation: 21 CFR 874.4680; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 14 days (middle half 14–14)
- Recalls: 0 (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)
- 1984: 1
- 1993: 1
- 2002: 1
- 2011: 1
- 2012: 1
- 2025: 1

## Most-cited predicates
- K121186: Radial Jaw 4 Pulmonary Biopsy Forceps (2012), cited by 1
- K102336: Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps; Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps with NE (2011), cited by 1

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