Data / Medical devices / United States / Syntr Health Technologies, Inc.
Syntr Health Technologies, Inc.: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
Syntr Health Technologies, Inc. is registered with the FDA (registration 3017791237) in Irvine, CA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 2, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017791237
- Address
- 9120 Irvine Center Dr Ste 200, Irvine, CA, United States, 92618
- Owner or operator
- Syntr Health Technologies, Inc. (10079670)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 17, 2020
- Registered through
- 2026
- Brand names listed
- SyntrFuge System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Lipoaspirate Washing System For Aesthetic Body Contouring | QKL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Suction, Lipoplasty | MUU | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 2, 2021 | K203800 | SyntrFuge System | MUU | Substantially Equivalent | Syntr Health Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Disposable
- All makers of System, Suction, Lipoplasty
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- All makers of Lipoaspirate Washing System For Aesthetic Body Contouring
Updated July 2, 2021. 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.