Data / Medical devices / United States / Nanosonics, Inc.
Nanosonics, Inc.: FDA-registered device maker in Indianapolis, IN, United States, 2 510(k) clearances
Nanosonics, Inc. is registered with the FDA (registration 3008894376) in Indianapolis, IN, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 5, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008894376
- Address
- 7205 E 87th St, Indianapolis, IN, United States, 46256
- Owner or operator
- Nanosonics Limited (10035569)
- Roles
- Manufacturer
- First device listed
- June 5, 2018
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Endoscope Channel Cleaner | SEW | 2 | Manufacturer | accessdata.fda.gov |
| High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist | OUJ | 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 |
|---|---|---|---|---|---|---|
| March 5, 2026 | K253267 | CORIS System | SEW | Substantially Equivalent | Nanosonics Limited | accessdata.fda.gov |
| April 24, 2018 | K173865 | trophon2 | OUJ | Substantially Equivalent | Nanosonics Limited | accessdata.fda.gov |
Compare with other makers
Updated March 5, 2026. 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.