Encore System
FDA 510(k) clearance K201238 · decided 2020-10-02
Clearance details
- K-number
- K201238
- Device name
- Encore System
- Applicant
- Siesta Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-05-07
- Decision date
- 2020-10-02
- Days to decision
- 148 days
- Clearance type
- Special
- Product code
- ORY
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Los Gatos, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Encore System (K213159) | Siesta Medical, Inc. | 2021-12-22 |
| Encore System (K183310) | Siesta Medical, Inc. | 2019-05-09 |
| ENCORE SYSTEM (K133680) | Siesta Medical, Inc. | 2014-03-26 |
| ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT (K121440) | Siesta Medical, Inc. | 2012-12-06 |
| ENCORE TONGUE SUSPENSION SYSTEM (K121814) | Siesta Medical, Inc. | 2012-11-07 |
| ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN (K111179) | Siesta Medical, Inc. | 2011-07-01 |
| PRELUDE III TONGUE SUSPENSION SYSTEM (K110127) | Siesta Medical, Inc. | 2011-04-08 |
| PRELUDE II TOUNGE SUSPENSION SYSTEM (K103179) | Siesta Medical, Inc. | 2010-12-20 |
| SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM (K101060) | Siesta Medical, Inc. | 2010-07-08 |
Recalls involving this device
No recalls on record reference this clearance.