Data / Medical devices / United Kingdom / Zethon Ltd
Zethon Ltd: FDA-registered device maker in ASTON CLINTON Buckinghamshire, United Kingdom, 1 510(k) clearance
Zethon Ltd is registered with the FDA (registration 3016172274) in ASTON CLINTON Buckinghamshire, United Kingdom. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 14, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016172274
- Address
- 2 Halton Brook Business Park Weston Road, ASTON CLINTON Buckinghamshire, United Kingdom, HP22 5WF
- Owner or operator
- Zethon Ltd (10058256)
- Roles
- Manufacturer
- First device listed
- December 6, 2019
- Registered through
- 2027
- Brand names listed
- hekaDrill
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | 2 | Manufacturer | accessdata.fda.gov |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | 1 | Manufacturer | accessdata.fda.gov |
| Motor, Drill, Electric | HBC | 2 | Manufacturer | accessdata.fda.gov |
| Motor, Drill, Pneumatic | HBB | 2 | Manufacturer | accessdata.fda.gov |
| Motor, Surgical Instrument, Ac-Powered | GEY | 1 | 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 |
|---|---|---|---|---|---|---|
| March 14, 2024 | K233958 | hekaDrill | ERL | Substantially Equivalent | Zethon, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- All makers of Motor, Surgical Instrument, Ac-Powered
- All makers of Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- All makers of Motor, Drill, Electric
- All makers of Motor, Drill, Pneumatic
- All makers of Drills, Burrs, Trephines & Accessories (Simple, Powered)
Updated March 14, 2024. 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.