Product code EWL
- Device name
- Prosthesis, Laryngeal (Taub)
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.3730
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240763 | FirstFit Surgical Kit | Freudenberg Medical, LLC | 2024-12-18 |
| K141380 | PROVOX FREEHANDS FLEXIVOICE | Atos Medical AB | 2014-09-26 |
| K131947 | PROVOX VEGA PUNCTURE SET | Atos Medical AB | 2013-10-18 |
| K092593 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) | Atos Medical AB | 2010-10-14 |
| K093258 | BLOM-SINGER INDWELLING TEP OCCLUDER | Helix Medical, LLC | 2010-03-03 |
| K090455 | PROVOX VEGA, MODEL 8130-8135 | Atos Medical AB | 2009-06-05 |
| K082206 | BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES | Helix Medical, LLC | 2008-09-04 |
| K043138 | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 | Atos Medical AB | 2004-11-22 |
| K022125 | PROVOX FREEHANDS HME, MODEL 7710 | Atos Medical AB | 2002-07-30 |
| K991587 | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS | Helix Medical, Inc. | 1999-06-25 |
| K974132 | VOICE MASTER PROSTHESIS | E. Benson Hood Lab, Inc. | 1998-02-25 |
| K971244 | PROVOX 2 VOICE PROSTHESIS SYSTEM | Atos Medical AB | 1997-06-06 |
| K945287 | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE | Helix Medical, Inc. | 1994-12-09 |
| K945288 | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE | Helix Medical, Inc. | 1994-12-02 |
| K940638 | PROVOX(TM) VOICE PROSTHESIS | Atos Medical AB | 1994-06-22 |
| K932120 | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES | Helix Medical, Inc. | 1994-04-15 |
| K932163 | BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET | Helix Medical, Inc. | 1993-12-15 |
| K930105 | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. | Helix Medical, Inc. | 1993-05-17 |
| K920090 | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET | Helix Medical, Inc. | 1992-09-10 |
| K912486 | SINGH SPEECH SYSTEM (SERIES 'SSS') | Exmoor Plastics , Ltd. | 1992-09-04 |
| K915761 | BIVONA-COLORADO VOICE PROSTHESIS | Bivona Medical Technologies | 1992-06-29 |
| K904729 | BLOM-SINGER SHOWER GUARD | Helix Medical, Inc. | 1991-02-28 |
| K902112 | BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT | Helix Medical, Inc. | 1990-08-01 |
| K900518 | BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT | Helix Medical, Inc. | 1990-06-14 |
| K881011 | BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS | Bivona Medical Technologies | 1988-05-13 |
| K871885 | ESKA-HERRMANN TRACHEOSTOMY VALVE | C.R. Bard, Inc. | 1987-06-08 |
| K861088 | BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS | Bivona Medical Technologies | 1986-04-02 |
| K854118 | DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS | Dacomed Corp. | 1986-03-17 |
| K854112 | FLEXIBLE GRASPING FORCEPS | Hood Laboratories | 1986-03-12 |
| K853940 | THE GRONINGEN VOICE PROSTHESIS | Hood Laboratories | 1985-12-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00813307010661 | InHealth Technologies; Blom-Singer; Advantage | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307011415 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307011392 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307011347 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307011316 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307011293 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307011262 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307011040 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307011026 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307011002 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307010982 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307010951 | InHealth Technologies; Blom-Singer; Dual Valve | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307010647 | InHealth Technologies; Blom-Singer; Advantage | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307010685 | InHealth Technologies; Blom-Singer; Advantage | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307010746 | InHealth Technologies; Blom-Singer; Advantage | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307010760 | InHealth Technologies; Blom-Singer; Advantage | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307010784 | InHealth Technologies; Blom-Singer; Advantage | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307010845 | InHealth Technologies; Blom-Singer; Advantage | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307010869 | InHealth Technologies; Blom-Singer; Advantage | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307010883 | InHealth Technologies; Blom-Singer; Advantage | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307010975 | InHealth Technologies; Blom-Singer; Dual Valve | Freudenberg Medical, LLC | 2018-01-01 |
| 00813307011118 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2017-01-01 |
| 00813307011132 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2017-01-01 |
| 00813307011170 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2017-01-01 |
| 00813307011194 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2017-01-01 |
| 00813307011217 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2017-01-01 |
| 00813307011231 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2017-01-01 |
| 00813307011101 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2017-01-01 |
| 00813307011088 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2017-01-01 |
| 00813307011064 | InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 2017-01-01 |