510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081815Substantially Equivalent

Vocalis Gel

Cytophil, Inc, Whitefish Bay WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081815 is the FDA 510(k) clearance record for VOCALIS GEL, a class II device, cleared for Cytophil, Inc. on under FDA product code MIX (System, Vocal Cord Medialization). FDA records list 8 510(k) clearances for Cytophil, Inc., from to . As of , FDA records show no recalls naming K081815.

Clearance record

Decision date
Received
(193 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
Cytophil, Inc. 5546 N Santa Monica Blvd., Whitefish Bay WI
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