EWL · Prosthesis, Laryngeal (Taub)
Ear, Nose, Throat · 21 CFR 874.3730 · Class 2
Overview
| Product Code | EWL |
|---|---|
| Device Name | Prosthesis, Laryngeal (Taub) |
| Regulation | 21 CFR 874.3730 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
Identification
A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.
Classification Rationale
Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240763 | FirstFit Surgical Kit | Freudenberg Medical, LLC | Dec 18, 2024 | SESE |
| K141380 | PROVOX FREEHANDS FLEXIVOICE | Atos Medical AB | Sep 26, 2014 | SESE |
| K131947 | PROVOX VEGA PUNCTURE SET | Atos Medical AB | Oct 18, 2013 | SESE |
| K092593 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) | Atos Medical AB | Oct 14, 2010 | SESK |
| K093258 | BLOM-SINGER INDWELLING TEP OCCLUDER | Helix Medical, LLC | Mar 3, 2010 | SESE |
| K090455 | PROVOX VEGA, MODEL 8130-8135 | Atos Medical AB | Jun 5, 2009 | SESE |
| K082206 | BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES | Helix Medical, LLC | Sep 4, 2008 | SESE |
| K043138 | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 | Atos Medical AB | Nov 22, 2004 | SESE |
| K022125 | PROVOX FREEHANDS HME, MODEL 7710 | Atos Medical AB | Jul 30, 2002 | SESE |
| K991587 | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS | Helix Medical, Inc. | Jun 25, 1999 | SESE |
| K974132 | VOICE MASTER PROSTHESIS | E. Benson Hood Lab, Inc. | Feb 25, 1998 | SESE |
| K971244 | PROVOX 2 VOICE PROSTHESIS SYSTEM | Atos Medical AB | Jun 6, 1997 | SESE |
| K945287 | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE | Helix Medical, Inc. | Dec 9, 1994 | SESE |
| K945288 | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE | Helix Medical, Inc. | Dec 2, 1994 | SESE |
| K940638 | PROVOX(TM) VOICE PROSTHESIS | Atos Medical AB | Jun 22, 1994 | SESE |
| K932120 | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES | Helix Medical, Inc. | Apr 15, 1994 | SESE |
| K932163 | BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET | Helix Medical, Inc. | Dec 15, 1993 | SESE |
| K930105 | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. | Helix Medical, Inc. | May 17, 1993 | SESE |
| K920090 | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET | Helix Medical, Inc. | Sep 10, 1992 | SESE |
| K912486 | SINGH SPEECH SYSTEM (SERIES 'SSS') | Exmoor Plastics , Ltd. | Sep 4, 1992 | SESE |
Top Applicants
- Helix Medical, Inc. — 10 clearances
- Atos Medical AB — 8 clearances
- Bivona Medical Technologies — 8 clearances
- American V. Mueller — 2 clearances
- Helix Medical, LLC — 2 clearances
