Data / Medical devices / New Zealand / Chitogel Limited
Chitogel Limited: FDA-registered device maker in Upper Hutt Wellington, New Zealand, 1 510(k) clearance
Chitogel Limited is registered with the FDA (registration 3014653790) in Upper Hutt Wellington, New Zealand. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 17, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014653790
- Address
- 68 Ward St Wallaceville, Upper Hutt Wellington, New Zealand, 5018
- Owner or operator
- Chitogel Limited (10057952)
- Roles
- Specification developer
- First device listed
- June 18, 2018
- Registered through
- 2026
- Brand names listed
- Chitogel Endoscopic Sinus Surgery Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Splint, Intranasal Septal | LYA | 1 | Specification developer | 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 17, 2017 | K172179 | Chitogel Endoscopic Sinus Surgery Kit | LYA | Substantially Equivalent | Chitogel, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 17, 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.