Identity
- Trade Name
- Provox Vega XtraSeal 20Fr 8mm 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. Provox Vega XtraSeal has an additional enlarged esophageal flange that is intended to solve problems with leakage around the voice prosthesis FDA UDI
- Model / Reference
- 8296 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. Provox Vega XtraSeal has an additional enlarged esophageal flange that is intended to solve problems with leakage around the voice prosthesis FDA UDI
Identifiers
- Catalog Number
- 8296 FDA UDI
- Primary DI / UDI-DI
- 07331791011009 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 — 8 Millimeter FDA UDI
Category: Tracheoesophageal speech valve, indwelling
Provox Vega XtraSeal 20Fr 8mm 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 15mm — 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.
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 388e7a48-c4f5-4c45-a998-0f6d6e98a31c 38 fields · synced Jun 1, 2026