# MGQ: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 145
- Recalls: 5 (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)
- 1998: 16
- 1999: 16
- 2000: 6
- 2001: 4
- 2002: 4
- 2003: 3
- 2004: 3
- 2005: 1
- 2009: 1
- 2017: 1

## Most-cited predicates
- K041342: Impruv a.I. Cream Wound and Skin Emulsion (2005), cited by 17
- K964240: Biafine Wound Dressing Emulsion (1997), cited by 13
- K011994: Acryderm Silver Anttimicrobial Wound Gel Model# a-002101 (2001), cited by 12
- K024367: Sinclair Wound and Skin Emulsion (2003), cited by 10
- K991202: Modification to Woun'dres (1999), cited by 6
- K013525: Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) (2002), cited by 4
- K020325: L.a.M. Ipm Wound Gel (2002), cited by 4
- K974251: X-Cell Wound Dressing (1998), cited by 3
- K024054: Xylos Xcell Antimicrobial Dressing (2003), cited by 3
- K040019: Silverseal (2004), cited by 3

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