Siesta Medical, Inc.
Siesta Medical, Inc. has 0 FDA recalls, 3 inspections, 10 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Sep 30, 2025 · NAI
- Latest 510(k)
- Dec 22, 2021
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Summary
- Recalls
- 0
- 510(k) Clearances
- 10
- Inspections
- 3
- Compliance Actions
- 0
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 30, 2025 | Los Gatos, CA | Devices | No Action Indicated (NAI) | 3008792120 |
| Dec 15, 2022 | Los Gatos, CA | Devices | Voluntary Action Indicated (VAI) | 3008792120 |
| Jul 28, 2014 | Los Gatos, CA | Devices | Voluntary Action Indicated (VAI) | 3008792120 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K213159 | Encore System | Dec 22, 2021 |
| K201238 | Encore System | Oct 2, 2020 |
| K183310 | Encore System | May 9, 2019 |
| K133680 | ENCORE SYSTEM | Mar 26, 2014 |
| K121440 | ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT | Dec 6, 2012 |
| K121814 | ENCORE TONGUE SUSPENSION SYSTEM | Nov 7, 2012 |
| K111179 | ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM… | Jul 1, 2011 |
| K110127 | PRELUDE III TONGUE SUSPENSION SYSTEM | Apr 8, 2011 |
| K103179 | PRELUDE II TOUNGE SUSPENSION SYSTEM | Dec 20, 2010 |
| K101060 | SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM | Jul 8, 2010 |