Home / Device Classification / EWL

EWL — Prosthesis, Laryngeal (Taub) Class II

FDA Device Classification

Classification Details

Product Code
EWL
Device Class
Class II
Regulation Number
874.3730
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240763freudenberg medicalFirstFit Surgical KitDecember 18, 2024
K141380atos medicalPROVOX FREEHANDS FLEXIVOICESeptember 26, 2014
K131947atos medicalPROVOX VEGA PUNCTURE SETOctober 18, 2013
K092593atos medicalPROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)October 14, 2010
K093258helix medicalBLOM-SINGER INDWELLING TEP OCCLUDERMarch 3, 2010
K090455atos medicalPROVOX VEGA, MODEL 8130-8135June 5, 2009
K082206helix medicalBLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-20September 4, 2008
K043138atos medicalPROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134November 22, 2004
K022125atos medicalPROVOX FREEHANDS HME, MODEL 7710July 30, 2002
K991587helix medicalBLOM-SINGER INDWELLING 2000 VOICE PROSTHESISJune 25, 1999
K974132e. benson hood labVOICE MASTER PROSTHESISFebruary 25, 1998
K971244atos medicalPROVOX 2 VOICE PROSTHESIS SYSTEMJune 6, 1997
K945287helix medicalINHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICEDecember 9, 1994
K945288helix medicalINHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICEDecember 2, 1994
K940638atos medicalPROVOX(TM) VOICE PROSTHESISJune 22, 1994
K932120helix medicalBLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHESApril 15, 1994
K932163helix medicalBLOM-SINGER VOICE PROSTHESIS FLUSHING PIPETDecember 15, 1993
K930105helix medicalBLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.May 17, 1993
K920090helix medicalBLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SETSeptember 10, 1992
K912486exmoor plasticsSINGH SPEECH SYSTEM (SERIES 'SSS')September 4, 1992