# Intact Medical Corporation

- Location (FDA's records): Framingham, MA
- FDA decisions: 4 (2006–2016): 4 510(k) clearances
- Product codes: KNW (4)
- Predicates its devices cite: 5 (4 its own); citations of its devices by later devices: 5 (4 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
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)

## Firms that cite its devices most
- Resitu Medical AB: 1 (https://510kreport.com/company/resitu-medical)

## Its most-cited devices
- K060413: Intact Breast Lesion Excision System and Advance (2006), cited by 2
- K152596: Intact® Gen2 System (2016), cited by 1
- K081057: Intact Breast Lesion Excision System with Intact Excision XL (2008), cited by 1
- K142477: Intact Advance and Intact Excision XL, Intact BLES (2014), cited by 1

## Recent decisions
- K152596: Intact® Gen2 System (Feb 15, 2016)
- K142477: Intact Advance and Intact Excision XL, Intact BLES (Dec 15, 2014)
- K081057: Intact Breast Lesion Excision System with Intact Excision XL (Jun 17, 2008)
- K060413: Intact Breast Lesion Excision System and Advance (Apr 27, 2006)

Source page: https://510kreport.com/company/intact-medical