Intact Medical Corporation
United StatesFDA applicant, unverified
- Devices
- 4
What Intact Medical Corporation makes
Intact Medical Corporation manufactures breast lesion excision systems designed for minimally invasive removal of breast tissue, including the Intact Breast Lesion Excision System with Excision XL, the Intact Gen2 System, and the Intact Advance. These devices are intended for use in biopsy and excision procedures, aiming to preserve surrounding tissue while targeting abnormal areas.
The company’s portfolio consists of Class II medical devices, all of which are authorised via the FDA’s 510(k) clearance process. These devices are listed under the FDA’s regulatory framework and are based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Intact® Gen2 System Ref K152596
Regimes: 510(k) Registry: 510(k)Intact Breast Lesion Excision System And Advance Ref K060413
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Intact Medical Corporation have in the registry?
The registry currently lists 4 devices for Intact Medical Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intact Medical Corporation's devices?
Among its 4 most recently registered devices, Intact Medical Corporation has devices listed in FDA 510(k) (4 devices).
What risk classes do Intact Medical Corporation's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Intact Medical Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Intact Medical Corporation in the registry?
The most recently registered devices listed for Intact Medical Corporation include INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL, Intact® Gen2 System, INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE and Intact Advance and Intact Excision XL, Intact BLES.