Product Code: EWL FDA class 2 21 CFR 874.3730

Prosthesis, Laryngeal (Taub)

Ear, Nose, Throat

The Taub laryngeal prosthesis is a device designed to restore voice function in patients following laryngectomy or laryngeal surgery by providing a means for the passage of air from the trachea to the pharynx to generate speech. It is classified as FDA Class 2, representing moderate risk, and requires 510(k) premarket clearance. The product code is EWL, regulated under 21 CFR 874.3730 in the Ear, Nose, Throat specialty. No special implant, life-sustaining, or GMP-exempt flags apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: EWL
Device Class: FDA class 2
Regulation Number: 874.3730
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 40 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240763	FirstFit Surgical Kit	Dec 18, 2024	Substantially Equivalent	Freudenberg Medical, LLC
K141380	PROVOX FREEHANDS FLEXIVOICE	Sep 26, 2014	Substantially Equivalent	Atos Medical AB
K131947	PROVOX VEGA PUNCTURE SET	Oct 18, 2013	Substantially Equivalent	Atos Medical AB
K092593	PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)	Oct 14, 2010	Unknown	Atos Medical AB
K093258	BLOM-SINGER INDWELLING TEP OCCLUDER	Mar 03, 2010	Substantially Equivalent	Helix Medical, LLC
K090455	PROVOX VEGA, MODEL 8130-8135	Jun 05, 2009	Substantially Equivalent	Atos Medical AB
K082206	BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES	Sep 04, 2008	Substantially Equivalent	Helix Medical, LLC
K043138	PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134	Nov 22, 2004	Substantially Equivalent	Atos Medical AB
K022125	PROVOX FREEHANDS HME, MODEL 7710	Jul 30, 2002	Substantially Equivalent	Atos Medical AB
K991587	BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS	Jun 25, 1999	Substantially Equivalent	Helix Medical, Inc.
K974132	VOICE MASTER PROSTHESIS	Feb 25, 1998	Substantially Equivalent	E. Benson Hood Lab, Inc.
K971244	PROVOX 2 VOICE PROSTHESIS SYSTEM	Jun 06, 1997	Substantially Equivalent	Atos Medical AB
K945287	INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE	Dec 09, 1994	Substantially Equivalent	Helix Medical, Inc.
K945288	INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE	Dec 02, 1994	Substantially Equivalent	Helix Medical, Inc.
K940638	PROVOX(TM) VOICE PROSTHESIS	Jun 22, 1994	Substantially Equivalent	Atos Medical AB
K932120	BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES	Apr 15, 1994	Substantially Equivalent	Helix Medical, Inc.
K932163	BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET	Dec 15, 1993	Substantially Equivalent	Helix Medical, Inc.
K930105	BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.	May 17, 1993	Substantially Equivalent	Helix Medical, Inc.
K920090	BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET	Sep 10, 1992	Substantially Equivalent	Helix Medical, Inc.
K912486	SINGH SPEECH SYSTEM (SERIES 'SSS')	Sep 04, 1992	Substantially Equivalent	Exmoor Plastics , Ltd.
K915761	BIVONA-COLORADO VOICE PROSTHESIS	Jun 29, 1992	Substantially Equivalent	Bivona Medical Technologies
K904729	BLOM-SINGER SHOWER GUARD	Feb 28, 1991	Substantially Equivalent	Helix Medical, Inc.
K902112	BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT	Aug 01, 1990	Substantially Equivalent	Helix Medical, Inc.
K900518	BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT	Jun 14, 1990	Substantially Equivalent	Helix Medical, Inc.
K881011	BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS	May 13, 1988	Substantially Equivalent	Bivona Medical Technologies
K871885	ESKA-HERRMANN TRACHEOSTOMY VALVE	Jun 08, 1987	Substantially Equivalent	C.R. Bard, Inc.
K861088	BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS	Apr 02, 1986	Substantially Equivalent	Bivona Medical Technologies
K854118	DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS	Mar 17, 1986	Substantially Equivalent	Dacomed Corp.
K854112	FLEXIBLE GRASPING FORCEPS	Mar 12, 1986	Substantially Equivalent	Hood Laboratories
K853940	THE GRONINGEN VOICE PROSTHESIS	Dec 13, 1985	Substantially Equivalent	Hood Laboratories
K842896	BLOM-SINGER LOW PRESSURE VOICE PROSTHES	Aug 17, 1984	Substantially Equivalent	American V. Mueller
K832967	DUCKBILL VOICE PROSTHESIS & TRACHEO	Dec 23, 1983	Substantially Equivalent	American V. Mueller
K832852	BLAISE-RATHAEL VOICE PROSTHESIS	Sep 29, 1983	Substantially Equivalent	Richards Medical Co., Inc.
K823749	LOW PRESSURE BLOM-SINGER VOICE PROSTHES	Jan 07, 1983	Substantially Equivalent	Bivona Medical Technologies
K821568	BLOW-SINGER TRACHEOSTOMA VALVE	Jul 26, 1982	Substantially Equivalent	Bivona Medical Technologies
K820737	PERISCOPE VOICE PROSTHESIS	Apr 09, 1982	Substantially Equivalent	Bivona Medical Technologies
K812982	BLOM-SINGER VOICE PROSTHESIS	Nov 24, 1981	Substantially Equivalent	Bivona Medical Technologies
K812864	SILASTIC VOICE PROSTHESIS	Nov 24, 1981	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials
K810020	PANJE VOICE PROSTHESIS	Feb 05, 1981	Substantially Equivalent	Xomed, Inc.
K800563	BLOM-SINGER DUCKBILL VOICE PROSTHESIS	Mar 25, 1980	Substantially Equivalent	Bivona Medical Technologies