Data / Medical devices / Australia / Enterix Pty Ltd.
Enterix Pty Ltd.: FDA-registered device maker in NORTH RYDE New South Wales, Australia, 2 510(k) clearances
Enterix Pty Ltd. is registered with the FDA (registration 3005311019) in NORTH RYDE New South Wales, Australia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 5, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005311019
- Address
- Unit 15/2 Eden Park Drive, NORTH RYDE New South Wales, Australia, 2113
- Owner or operator
- Enterix Inc (9042500)
- Roles
- Manufacturer
- First device listed
- September 5, 2014
- Registered through
- 2026
- Brand names listed
- InSure FIT FOBT Controls, InSure ONE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Fecal Occult Blood | OSL | 2 | Manufacturer | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 5, 2017 | K170548 | InSure ONE | KHE | Substantially Equivalent | Enterix, Inc. | accessdata.fda.gov |
| October 1, 2010 | K101831 | ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 | OSL | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 5, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.