Sutura, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Sutura, Inc. makes
Sutura, Inc. manufactures vascular suturing devices, including the SUPERSTITCH 5F, 12F, and EL variants, as well as the SUPERSTITCH VASCULAR SUTURING DEVICE in 6 French sizes (06-15-00X and 06-25-00X models) and GW variants (06-15-04-GW, 08-15-04-GW). These devices are designed for surgical applications in blood vessels, providing controlled suturing for vascular repairs.
The company’s vascular suturing devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Superstitch 5F, 12F, And El Ref K062125
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Superstitch Gw, Models 06-15-04-Gw, 08-15-04-Gw Ref K053482
Regimes: 510(k) Registry: 510(k)Superstitch Ref K994087
Regimes: 510(k) Registry: 510(k)Superstitch Vascular Suturing Device Ref K012865
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sutura, Inc. have in the registry?
The registry currently lists 5 devices for Sutura, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sutura, Inc.'s devices?
Among its 5 most recently registered devices, Sutura, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Sutura, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Sutura, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sutura, Inc. in the registry?
The most recently registered devices listed for Sutura, Inc. include SUPERSTITCH 5F, 12F, AND EL, SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X, SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW and SUPERSTITCH.