Identity
- Trade Name
- Encore System FDA UDI
- Generic Name
- Sleep apnoea tongue implant, non-bioabsorbable FDA UDI
- Device Name
- Implants and delivery tools for hyoid and tongue suspension. FDA UDI
- Model / Reference
- FG0002 FDA UDI
- Description
- Implants and delivery tools for hyoid and tongue suspension. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00862211000206 FDA UDI
- 510(k) Number
- K133680 FDA UDI
- FDA Product Code
- ORY FDA UDI
- GMDN Term
- Sleep apnoea tongue implant, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sleep apnoea tongue implant, non-bioabsorbable
Encore System by Siesta Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siesta Medical, Inc.
Sources (1)
- FDA UDI 5ba93e0f-9df4-4142-a84c-cd29ee791fee 34 fields · synced May 30, 2026