Provox2 Voice Prosthesis 12.5mm

FDA UDI

Class II (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name: Provox2 Voice Prosthesis 12.5mm FDA UDI
Generic Name: Tracheoesophageal speech valve, indwelling FDA UDI
Device Name: Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device. FDA UDI
Model / Reference: 7221 FDA UDI
Description: Provox2 is an indwelling, low resistance voice prosthesis intended for voice restoration after total laryngectomy. Provox2 is intended for both antero- and retrograde insertion at time of surgery or as replacement device. FDA UDI

Identifiers

Catalog Number: 7221 FDA UDI
Primary DI / UDI-DI: 07331791010064 FDA UDI
510(k) Number: K971244 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 12.5 Millimeter FDA UDI

Category: Tracheoesophageal speech valve, indwelling

Provox2 Voice Prosthesis 12.5mm by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Tracheoesophageal speech valve, indwelling.

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Cleared under the same submission

K971244 also covers:

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 64ebf3c7-0309-4396-911f-ba0559463b73 38 fields · synced Jun 8, 2026