Gastrotech, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Gastrotech, Inc. makes
Gastrotech, Inc. manufactures feeding tubes for gastrostomy and percutaneous endoscopic gastrostomy (PEG), including syringe injection gun delivery kits and esophageal overtubes. These products are designed for enteral nutrition and medication administration in patients requiring long-term support.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Gastrostomy Feeding Tube Ref K883336
Regimes: 510(k) Registry: 510(k)Syringe Injection Gun Delivery Kits Ref K890658
Regimes: 510(k) Registry: 510(k)Esophageal Overtube Ref K890629
Regimes: 510(k) Registry: 510(k)Syringe Injection Gun Ref K862853
Regimes: 510(k) Registry: 510(k)Percutaneous Endoscopic Gastrostomy Feeding Tube Ref K883351
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gastrotech, Inc. have in the registry?
The registry currently lists 5 devices for Gastrotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gastrotech, Inc.'s devices?
Among its 5 most recently registered devices, Gastrotech, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Gastrotech, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Gastrotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gastrotech, Inc. in the registry?
The most recently registered devices listed for Gastrotech, Inc. include GASTROSTOMY FEEDING TUBE, SYRINGE INJECTION GUN DELIVERY KITS, ESOPHAGEAL OVERTUBE and SYRINGE INJECTION GUN.