# PBQ: Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use

- Device class: 2; regulation: 21 CFR 884.4530; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 123 days (middle half 120–127)
- 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)
- 2004: 1
- 2012: 1
- 2013: 1
- 2016: 1
- 2022: 2
- 2023: 1
- 2026: 1

## Most-cited predicates
- K120831: Anchorsure (2012), cited by 2
- K042603: Gynecare Prolene Fastener System (2004), cited by 1
- K230730: Apyx (2023), cited by 1
- K213783: Apyx (2022), cited by 1
- K160569: NeuGuide (2016), cited by 1

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