Data / Medical devices / United States / The Reflux Company
The Reflux Company: FDA-registered device maker in San Diego, CA, United States, 3 510(k) clearances
The Reflux Company is registered with the FDA (registration 3039167637) in San Diego, CA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 13, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039167637
- Address
- 7868 Silverton Ave Ste J, San Diego, CA, United States, 92126
- Owner or operator
- The Reflux Company (10093713)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 26, 2025
- Registered through
- 2026
- Brand names listed
- Dx-pH, Dx201, Dx201L, Dx201P, MDRF1 Generator, Reflux Band, SECCA Handpiece and Accessory Kit, Stretta and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Ph, Stomach | FFT | 1 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Specification developer | accessdata.fda.gov |
| External Upper Esophageal Sphincter (Ues) Compression Device | PKA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Transducer, Miniature Pressure | IKE | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 13, 2018 | K173934 | Reza Band, Reflux Band | PKA | Substantially Equivalent | Somna Therapeutics, LLC | accessdata.fda.gov |
| September 23, 2015 | K152317 | Stretta Catheter | GEI | Substantially Equivalent | Mederi Therapeutics, Inc. | accessdata.fda.gov |
| March 21, 2002 | K014216 | SECCA SYSTEM | GEI | Substantially Equivalent | Curon Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Ph, Stomach
- All makers of Transducer, Miniature Pressure
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated April 13, 2018. 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.