# PGZ: Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

- Device class: 2; regulation: 21 CFR 878.4452; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 110 days (middle half 77–142)
- 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: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2021: 1
- 2025: 1

## Most-cited predicates
- K152624: Xstat 30, 3-Pack, Xstat 30, 1-Pack (2015), cited by 2
- DEN130016: XSTAT (2014), cited by 1
- K170334: XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack (2017), cited by 1
- K180051: XSTAT 30, 1-Pack (2018), cited by 1
- K210676: XSTAT 30 Pouch (2021), cited by 1
- K161020: XSTAT-12, 3-Pack, XSTAT-12, 1-Pack (2016), cited by 1

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