Imagyn Surgical
Country not established
- Devices
- 3
What Imagyn Surgical makes
Imagyn Surgical manufactures breast biopsy devices in 5 mm, 10 mm, 15 mm, and 22 mm sizes, designed for tissue sampling, and an endotracheal cardiac output monitor for real-time hemodynamic assessment.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Ecom Endotrachial Cardiac Output Monitor Ref K021174
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Imagyn Surgical have in the registry?
The registry currently lists 3 devices for Imagyn Surgical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Imagyn Surgical's devices?
Among its 3 most recently registered devices, Imagyn Surgical has devices listed in FDA 510(k) (3 devices).
What risk classes do Imagyn Surgical's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Imagyn Surgical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Imagyn Surgical in the registry?
The most recently registered devices listed for Imagyn Surgical include 22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022, 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE and ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR.