Data / Medical devices / United States / Ebr Systems Inc.
Ebr Systems Inc.: FDA-registered device maker in Sunnyvale, CA, United States, 2 510(k) clearances and 1 PMA approval
Ebr Systems Inc. is registered with the FDA (registration 3013596742) in Sunnyvale, CA, United States. It lists 7 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated April 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013596742
- Address
- 480 Oakmead Pkwy, Sunnyvale, CA, United States, 94085
- Owner or operator
- EBR Systems Inc. (10092727)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- February 11, 2025
- Registered through
- 2026
- Brand names listed
- Coupler, Retractor, Steam Sterilization Top Container, Sterilization wrap Bottom Container, Surgical Forceps, Uterine Dilator, WiSE (Wireless Stimulation of the Endocardium Technology) CRT System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cardiovascular Delivery Catheter System Positioning And Stabilization Device | QWA | 1 | Manufacturer | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Leadless Cardiac Resynchronization Therapy (Crt) | SEG | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sterilizer, Steam | FLE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | 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 |
|---|---|---|---|---|---|---|
| February 15, 2006 | K053389 | AESCULAP STERILCONTAINER SYSTEM | FRG | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| December 27, 1979 | K792558 | CONTAINER SYSTEM | FLE | Substantially Equivalent | Aesculap Instruments Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 11, 2025 | P240028 | WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System | SEG | 5 | March 27, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Cervical, Fixed Size
- All makers of Retractor
- All makers of Wrap, Sterilization
- All makers of Sterilizer, Steam
- All makers of Cardiovascular Delivery Catheter System Positioning And Stabilization Device
Updated March 27, 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.