# Sxwell USA, LLC

- Location (FDA's records): Iselin, NJ
- FDA decisions: 2 (2017–2018): 2 510(k) clearances
- Product codes: NUC (1), MOL (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Church & Dwight Co., Inc.: 1 (https://510kreport.com/company/church-dwight)
- Ansell Healthcare Products, LLC: 1 (https://510kreport.com/company/ansell-healthcare-products)

## Recent decisions
- K182438: Synthetic Polyisoprene Lubricated Male Condom - 5 senses (Dec 6, 2018)
- K172473: LifeStyles® SKYN® Intimate Moments Personal Lubricant (Dec 15, 2017)

Source page: https://510kreport.com/company/sxwell-usa