510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082206Substantially Equivalent

Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models Dv-1600 Series, Dv-2000 Series

Freudenberg Medical, LLC, Carpinteria CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082206 is the FDA 510(k) clearance record for BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES, a class II device, cleared for Helix Medical, LLC on under FDA product code EWL (Prosthesis, Laryngeal (Taub)). FDA records list 21 510(k) clearances for Freudenberg Medical, LLC, from to . As of , FDA records show no recalls naming K082206.

Clearance record

Decision date
Received
(30 days to decision)
Product code
EWL Prosthesis, Laryngeal (Taub)
Regulation
21 CFR 874.3730
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Helix Medical, LLC 1110 Mark Ave., Carpinteria CA
510(k) summary
Summary PDF
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