# PGT: Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar

- Device class: 2; regulation: 21 CFR 884.1710; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 58 days (middle half 58–58)
- 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)
- 2014: 2
- 2024: 1

## Most-cited predicates
- DEN130040: Iogyn System (2014), cited by 1
- K141848: Iogyn System (2014), cited by 1

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