Data / Medical devices / United States / Histosonics, Inc
Histosonics, Inc: FDA-registered device maker in Plymouth, MN, United States, 2 510(k) clearances
Histosonics, Inc is registered with the FDA (registration 3027664504) in Plymouth, MN, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 30, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3027664504
- Address
- 16305 36th Avenue North Suite 300, Plymouth, MN, United States, 55446
- Owner or operator
- HistoSonics, Inc (10088809)
- Roles
- Manufacturer
- First device listed
- April 30, 2024
- Registered through
- 2026
- Brand names listed
- Edison System, Fluidics System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation | QGM | 2 | Manufacturer | accessdata.fda.gov |
| Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | JRS | 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 |
|---|---|---|---|---|---|---|
| October 30, 2024 | K241902 | Edison System | QGM | Substantially Equivalent | HistoSonics, Inc. | accessdata.fda.gov |
| March 13, 2024 | K233466 | Edison System | QGM | Substantially Equivalent | HistoSonics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 30, 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.