# LWH: Counter, Sponge, Surgical

- Device class: 1; regulation: 21 CFR 880.2740; FDA's rule: 510(k) exempt
- FDA decisions: 15
- Recalls: 2 (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)
- 1987: 1
- 1991: 1
- 1995: 1
- 1997: 1
- 1998: 1
- 2006: 3
- 2007: 2
- 2009: 1
- 2010: 1
- 2012: 2

## Most-cited predicates
- K060076: Surgicount Safety-Sponge System (2006), cited by 3
- K062642: RF Surgical Systems Inc. Detection System, Model 100A (2006), cited by 3
- K071355: Smartsponge System (2007), cited by 2
- K073180: Smartsponge Plus System (2007), cited by 1
- K912824: Devon Sponge Counter Bags (1991), cited by 1
- K093557: Smartwand-DTX (2009), cited by 1

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