510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832967Substantially Equivalent

Duckbill Voice Prosthesis & Tracheo

American V. Mueller, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832967 is the FDA 510(k) clearance record for DUCKBILL VOICE PROSTHESIS & TRACHEO, a class II device, cleared for American V. Mueller on under FDA product code EWL (Prosthesis, Laryngeal (Taub)). FDA records list 31 510(k) clearances for American V. Mueller, from to . As of , FDA records show no recalls naming K832967.

Clearance record

Decision date
Received
(113 days to decision)
Product code
EWL Prosthesis, Laryngeal (Taub)
Regulation
21 CFR 874.3730
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
American V. Mueller 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EWL

Trailing 12 months

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

FDA records show no clearances under product code EWL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EWL, 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