# GZT: Retractor, Self-Retaining, For Neurosurgery

- Device class: 2; regulation: 21 CFR 882.4800; FDA's rule: 510(k) required
- FDA decisions: 44
- 510(k) review time 2021–2025: median 279 days (middle half 200–359)
- Recalls: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 1
- 2012: 2
- 2015: 1
- 2016: 1
- 2017: 3
- 2018: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2026: 1

## Most-cited predicates
- K992898: The Bright Medical Dilation Retractor System (1999), cited by 6
- K964402: Versatrac (TM) Lumbar Retractor System (1997), cited by 5
- K830332: Budde-Halo Retractor (1983), cited by 4
- K935529: Cervical Self-Retaining Retractor (1994), cited by 2
- K895395: V. Mueller Rhoton Self-Retaining Brain Retractor (1989), cited by 2
- K120691: Brain Port (2012), cited by 2
- K913233: Codman Lhalo Split Ring Retractor System (1991), cited by 2
- K960807: Tew Cranial/Spinal Retractor Model A1090 (1996), cited by 2
- K060097: Grossman Self-Retaining Low Profile Brain Retractor, Model 04-001-00 (2006), cited by 2
- K062814: Pipeline II Access System (2006), cited by 2

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