FDA.reportPublic FDA data

SilkVoice

Primary DI
B611SV10011
Brand
SilkVoice
Company
SOFREGEN MEDICAL INC.
Model
SV1001
Catalog number
SV1001
Device description
SilkVoice Injectable Implant, 1cc Syringe, 2 needles
Published
2020-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MIXSystem, Vocal Cord Medialization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIXSystem, Vocal Cord MedializationEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180631000Silk VoiceSofregen Medical, Inc.2018-11-08MIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B611SV10011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Injectable vocal cord medialization implant, syntheticAn implantable synthetic material [e.g., calcium hydroxyapatite, polytetrafluoroethylene (PTFE) -- commonly known as Teflon] designed as a space-occupying bulking agent to treat patients with unilateral vocal cord paralysis to improve voice quality. The device is typically available in a sterile syringe with needle, and is injected into the paralyzed vocal cord tissue, filling it and shifting it midline (vocal cord medialization). The properties of the device may facilitate ingrowth of the surrounding tissue over time. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079710838
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6119467707SERI946772018-03-02
B6119467808SERI946782018-03-02
B6119467909SERI946802018-03-02
B6119468001SERI946792018-03-02
B611955121SERI Contour95512955122018-03-08
B611SV1002SilkVoiceSV1002SV10022021-07-21
B611SV10021SilkVoiceSV1002SV10022021-07-21
B611SV2001SilkVoiceSV2001SV20012021-07-21
B611SV3001SilkVoiceSV3001SV30012021-07-21
B611SV30012SilkVoiceSV3001SV30012021-07-21
B611SV1001SilkVoiceSV1001SV10012020-03-01
B611SV20011SilkVoiceSV2001SV20012020-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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