Emcision, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 10
What Emcision, Ltd. makes
Emcision, Ltd. manufactures radiofrequency ablation (RFA) devices and energy-based sealing systems designed for endoscopic and laparoscopic procedures. Their portfolio includes tools like the Habib EndoHPB for hepatic ablation, the Habib Hexablate series for tissue coagulation, and the Habib Vesel for vascular sealing. Additional products like the Habib Endoblate and Habib 4X are tailored for targeted tissue ablation and precision energy delivery in minimally invasive surgeries.
All listed devices fall under Class II regulatory classification in the US, with authorisation via the FDA 510(k) pathway. The company’s products are registered under this framework, ensuring compliance with US medical device regulations. Emcision, Ltd. is based in the United States.
Catalogue
Habib EUS RFA Ref K150029
Regimes: 510(k) Registry: 510(k)Habib Laparoscopic Hexablate Ref K073687
Regimes: 510(k) Registry: 510(k)Habib EUS RFA Ref K161305
Regimes: 510(k) Registry: 510(k)Habib Endoblate Ref K072383
Regimes: 510(k) Registry: 510(k)Habib Veseal Ref K072126
Regimes: 510(k) Registry: 510(k)Habib EndoHPB Ref K180165
Regimes: 510(k) Registry: 510(k)Habib Endohpb Ref K083292
Regimes: 510(k) Registry: 510(k)Habib Hexablate Ref K071103
Regimes: 510(k) Registry: 510(k)Habib Hexablate 10 Ref K080717
Regimes: 510(k) Registry: 510(k)Habib 4X Ref K051420
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Emcision, Ltd. have in the registry?
The registry currently lists 10 devices for Emcision, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Emcision, Ltd.'s devices?
Among its 10 most recently registered devices, Emcision, Ltd. has devices listed in FDA 510(k) (10 devices).
What risk classes do Emcision, Ltd.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Emcision, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Emcision, Ltd. in the registry?
The most recently registered devices listed for Emcision, Ltd. include Habib EUS RFA, HABIB LAPAROSCOPIC HEXABLATE, HABIB ENDOBLATE and HABIB VESEAL.