# GBL: Catheter, Ureteral, General & Plastic Surgery

- Device class: N; regulation: 21 CFR 876.5130; FDA's rule: Pathway set case by case
- FDA decisions: 0
- 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)

## Most-cited predicates

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