510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K240919Substantially Equivalent

Silk Voice (SMI-04)

Sofregen Medical, Inc., Framingham MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240919 is the FDA 510(k) clearance record for Silk Voice (SMI-04), a class II device, cleared for Sofregen Medical on under FDA product code MIX (System, Vocal Cord Medialization). FDA records list 3 510(k) clearances for Sofregen Medical, from to . As of , FDA records show no recalls naming K240919.

Clearance record

Decision date
Received
(30 days to decision)
Product code
MIX System, Vocal Cord Medialization
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Sofregen Medical 175 Crossing Blvd., Suite 510, Framingham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MIX

Trailing 12 months

FDA records hold no clearances under product code MIX in the trailing twelve months.

FDA records show no clearances under product code MIX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MIX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260