Care Wise Medical Products Corp.
United StatesFDA applicant, unverified
- Devices
- 4
What Care Wise Medical Products Corp. makes
Care Wise Medical Products Corp. manufactures diagnostic systems for cancer detection and biopsy analysis, including the ONCOPROBE System for real-time tissue analysis and the C-TRAK Biopsy System for sample processing. The C-TRAK Automatic Analyzer (formerly ONCOPROBE II) provides automated analysis of biopsy specimens, supporting intraoperative decision-making.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States, with its products authorised for commercial distribution in the US market.
Catalogue
Oncoprobe System Ref K884770
Regimes: 510(k) Registry: 510(k)C-Trak Biopsy System Ref K922117
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Oncoprobe Ii System Ref K896588
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Care Wise Medical Products Corp. have in the registry?
The registry currently lists 4 devices for Care Wise Medical Products Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Care Wise Medical Products Corp.'s devices?
Among its 4 most recently registered devices, Care Wise Medical Products Corp. has devices listed in FDA 510(k) (4 devices).
What risk classes do Care Wise Medical Products Corp.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Care Wise Medical Products Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Care Wise Medical Products Corp. in the registry?
The most recently registered devices listed for Care Wise Medical Products Corp. include ONCOPROBE SYSTEM, C-TRAK BIOPSY SYSTEM, C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) and ONCOPROBE II SYSTEM.