# KGW: Ring (Wound Protector), Drape Retention, Internal

- Device class: 2; regulation: 21 CFR 878.4370; FDA's rule: 510(k) exempt
- FDA decisions: 9
- 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)
- 1979: 1
- 1984: 1
- 2004: 1
- 2007: 1
- 2009: 1
- 2010: 1
- 2013: 1
- 2026: 2

## Most-cited predicates
- K041711: Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304 (2004), cited by 6
- K062907: Alexis Wound Retractor (2007), cited by 1
- K253531: Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) (2026), cited by 1

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