Identity
- Trade Name
- Provox Vega 20Fr 15mm FDA UDI
- Generic Name
- Tracheoesophageal speech valve, indwelling FDA UDI
- Device Name
- Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The Provox Insertion System is a single-use replacement device intended for anterograde insertion only. FDA UDI
- Model / Reference
- 8281 FDA UDI
- Description
- Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The Provox Insertion System is a single-use replacement device intended for anterograde insertion only. FDA UDI
Identifiers
- Catalog Number
- 8281 FDA UDI
- Primary DI / UDI-DI
- 07331791010859 FDA UDI
- 510(k) Number
- K090455 FDA UDI
- FDA Product Code
- EWL FDA UDI
- GMDN Term
- Tracheoesophageal speech valve, indwelling FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3730 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 15 Millimeter FDA UDI
Category: Tracheoesophageal speech valve, indwelling
Provox Vega 20Fr 15mm by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheoesophageal speech valve, indwelling.
- InHealth Technologies; Blom-Singer; Advantage — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer; Dual Valve — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer; Dual Valve — FREUDENBERG MEDICAL, LLC · Class I
- InHealth Technologies — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer; Advantage — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer; Classic — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer; Classic — FREUDENBERG MEDICAL, LLC · Class I
Cleared under the same submission
K090455 also covers:
- Provox Vega 17Fr 10mm — ATOS MEDICAL INC.
- Provox Vega 17Fr 12.5mm — ATOS MEDICAL INC.
- Provox Vega 17Fr 15mm — ATOS MEDICAL INC.
- Provox Vega 17Fr 8mm — ATOS MEDICAL INC.
- Provox Vega 20Fr 10mm — ATOS MEDICAL INC.
- Provox Vega 20Fr 12.5mm — ATOS MEDICAL INC.
- Provox Vega 20Fr 6mm — ATOS MEDICAL INC.
- Provox Vega 20Fr 8mm — ATOS MEDICAL INC.
- Provox Vega 22.5Fr 12.5mm — ATOS MEDICAL INC.
- Provox Vega 22.5Fr 15mm — ATOS MEDICAL INC.
- Provox Vega 22.5Fr 4mm — ATOS MEDICAL INC.
- Provox Vega 22.5Fr 6mm — ATOS MEDICAL INC.
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
- Atos Medical Inc.
Sources (1)
- FDA UDI e08853a3-e4aa-418c-9cfd-3d337ea1b4aa 38 fields · synced May 30, 2026