Data / Medical devices / United States / Siesta Medical, Inc.
Siesta Medical, Inc.: FDA-registered device maker in Los Gatos, CA, United States, 1 510(k) clearance
Siesta Medical, Inc. is registered with the FDA (registration 3008792120) in Los Gatos, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008792120
- Address
- 101 Church St, Los Gatos, CA, United States, 95030
- Owner or operator
- Siesta Medical, Inc. (10033959)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 3, 2015
- Registered through
- 2026
- Brand names listed
- Encore Revision Kit, Encore System, Revolution Suture Passer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Passer | HWQ | 1 | Manufacturer | accessdata.fda.gov |
| Tongue Suspension System | ORY | 2 | Manufacturer | accessdata.fda.gov |
| Wrench | HXC | 1 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| December 22, 2021 | K213159 | Encore System | ORY | Substantially Equivalent | Siesta Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 22, 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.