# Imagyn Surgical

- Location (FDA's records): Richland, MI
- FDA decisions: 3 (1999–2003): 3 510(k) clearances
- Product codes: KNW (2), DSB (1)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 4 (1 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
- Sometec, Inc.: 1 (https://510kreport.com/company/sometec)
- Cardiodynamics International Corp.: 1 (https://510kreport.com/company/cardiodynamics-international)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Applied Biometrics, Inc.: 1 (https://510kreport.com/company/applied-biometrics)
- Urothealth System, Inc.: 1 (https://510kreport.com/company/urothealth-system)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)

## Firms that cite its devices most
- Scion International, Inc.: 1 (https://510kreport.com/company/scion-international)
- Imagyn Medical Technologies, Inc.: 1 (https://510kreport.com/company/imagyn-medical-technologies)
- Artemis Medical, Inc.: 1 (https://510kreport.com/company/artemis-medical)

## Its most-cited devices
- K993936: 15MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device, 5MM Siteselect Breast Biopsy Device (1999), cited by 2
- K021174: Ecom Endotrachial Cardiac Output Monitor (2003), cited by 1
- K011575: 22MM Siteselect Breast Biopsy Device Model SSD022 (2001), cited by 1

## Recent decisions
- K021174: Ecom Endotrachial Cardiac Output Monitor (Apr 29, 2003)
- K011575: 22MM Siteselect Breast Biopsy Device Model SSD022 (Aug 17, 2001)
- K993936: 15MM Siteselect Breast Biopsy Device, 10 MM Siteselect Breast Biopsy Device, 5MM Siteselect Breast Biopsy Device (Dec 27, 1999)

Source page: https://510kreport.com/company/imagyn-surgical