Neothermia Corp.
United StatesFDA applicant, unverified
- Devices
- 10
What Neothermia Corp. makes
Neothermia Corp. manufactures modifications and variants of en-bloc biopsy systems, including specific models (e.g., 777-110, 777-120, 770-001). These devices are designed for tissue sampling procedures, facilitating the removal of intact tissue cores for diagnostic analysis.
The company’s portfolio consists of Class II medical devices, all of which are listed via the FDA’s 510(k) pathway. These devices are regulated under US jurisdiction, where Neothermia Corp. is based.
Catalogue
En-Bloc Biopsy System MODEL#777-110, 777-001, 777-002, 777-006, 777-301, 777-302, 777-115, 777-120 Ref K042170
Regimes: 510(k) Registry: 510(k)Modification To En-Bloc Biopsy System Ref K033427
Regimes: 510(k) Registry: 510(k)Modification To En-Bloc Biopsy System Ref K022296
Regimes: 510(k) Registry: 510(k)Modification To En-Bloc Biopsy System Ref K052246
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
En Bloc Biopsy System Ref K003190
Regimes: 510(k) Registry: 510(k)Modification To En-Bloc Biopsy System Ref K041347
Regimes: 510(k) Registry: 510(k)Modification To En-Bloc Biopsy System Ref K021577
Regimes: 510(k) Registry: 510(k)Neothermia En-Bloc Biopsy System Ref K050737
Regimes: 510(k) Registry: 510(k)En-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 Ref K020031
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Neothermia Corp. have in the registry?
The registry currently lists 10 devices for Neothermia Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neothermia Corp.'s devices?
Among its 10 most recently registered devices, Neothermia Corp. has devices listed in FDA 510(k) (10 devices).
What risk classes do Neothermia Corp.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Neothermia Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Neothermia Corp. in the registry?
The most recently registered devices listed for Neothermia Corp. include EN-BLOC BIOPSY SYSTEM MODEL#777-110, 777-001, 777-002, 777-006, 777-301, 777-302, 777-115, 777-120, MODIFICATION TO EN-BLOC BIOPSY SYSTEM, MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM and EN BLOC BIOPSY SYSTEM.