Tusker Medical, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Tusker Medical, Inc. makes
Tusker Medical, Inc. manufactures the Tula Tympanostomy Tube Delivery Device, a system for inserting tympanostomy tubes in pediatric ear surgery, and the Tula System, a reusable surgical tool designed for precise tube placement. Both products are intended to assist in otolaryngological procedures requiring controlled tube insertion.
The company’s portfolio includes devices classified as Class II and Class III under FDA regulations, with submissions recorded via 510(k) clearances and PMA applications. These products are listed in the U.S. regulatory database and are intended for use within the country.
Catalogue
Tula Tympanostomy Tube Delivery Device Ref K252436
510(k) 510(k)TULA Tube Delivery System Ref K171239
510(k) 510(k)Tula System Ref P190016
PMA PMA
Frequently asked questions
How many devices does Tusker Medical, Inc. have in the registry?
The registry currently lists 3 devices for Tusker Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tusker Medical, Inc.'s devices?
Among its 3 most recently registered devices, Tusker Medical, Inc. has devices listed in FDA 510(k) (2 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Tusker Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Tusker Medical, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Tusker Medical, Inc. in the registry?
The most recently registered devices listed for Tusker Medical, Inc. include Tula Tympanostomy Tube Delivery Device, TULA Tube Delivery System and Tula System.