Suturtek Incorporated
United StatesFDA applicant, unverified
- Devices
- 4
What Suturtek Incorporated makes
Suturtek Incorporated manufactures sternum closure devices, including mechanical systems for rapid sternal approximation and 360-degree sternal fixation, as well as surgical steel sutures designed for cardiac and thoracic procedures. Their portfolio includes a fast-closing sternal device and a suturing device intended for internal fixation during open-chest surgeries.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. These devices are listed in the FDA’s 510(k) database, reflecting their regulatory authorisation in the United States.
Catalogue
Suturtek Fastclose Sternum Closure Device Ref K032468
Regimes: 510(k) Registry: 510(k)Suturtek 360 Degree Sternal Closure Device Ref K082828
Regimes: 510(k) Registry: 510(k)Suturtek Fastclose Suturing Device Ref K030227
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Suturtek Incorporated have in the registry?
The registry currently lists 4 devices for Suturtek Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suturtek Incorporated's devices?
Among its 4 most recently registered devices, Suturtek Incorporated has devices listed in FDA 510(k) (4 devices).
What risk classes do Suturtek Incorporated's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Suturtek Incorporated's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Suturtek Incorporated in the registry?
The most recently registered devices listed for Suturtek Incorporated include SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE, SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE, SUTURTEK FASTCLOSE SUTURING DEVICE and SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17.