Entech, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Entech, Inc. makes
Entech, Inc. manufactures enteral nutrition products, including feeding tubes (such as the ENTube™ and Meer feeding tube bridle system), enteral feeding containers (EnTAINER™), preattached feeding bag sets with ports, percutaneous endoscopic gastrostomy (PEG) and percutaneous fluoroscopy-guided (PFG) feeding devices, and enteral administration pumps and sets (Entech Enteral Pump, ENFuse set).
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Entube Tm, Enteral Feeding Tube Ref K861427
Regimes: 510(k) Registry: 510(k)Entainer(Tm) Enteral Feeding Container Ref K890430
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Entube-Meer And Meer Feeding Tube Bridle System Ref K873343
Regimes: 510(k) Registry: 510(k)Gilsdorf Percu. Endo.-Peg & Percu. Flouro.-Pfg Ref K891371
Regimes: 510(k) Registry: 510(k)Entech Enteral Pump And Set Ref K873444
Regimes: 510(k) Registry: 510(k)Enfuse Enternal Administration Set & Pump Set Ref K871019
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Entech, Inc. have in the registry?
The registry currently lists 7 devices for Entech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Entech, Inc.'s devices?
Among its 7 most recently registered devices, Entech, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Entech, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Entech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Entech, Inc. in the registry?
The most recently registered devices listed for Entech, Inc. include ENTUBE TM, ENTERAL FEEDING TUBE, ENTAINER(TM) ENTERAL FEEDING CONTAINER, TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS and ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM.