EWL — Prosthesis, Laryngeal (Taub) Class II
FDA product code EWL covers "Prosthesis, Laryngeal (Taub)", a Class II medical device regulated under 21 CFR 874.3730. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240763 | freudenberg medical | FirstFit Surgical Kit | December 18, 2024 |
| K141380 | atos medical | PROVOX FREEHANDS FLEXIVOICE | September 26, 2014 |
| K131947 | atos medical | PROVOX VEGA PUNCTURE SET | October 18, 2013 |
| K092593 | atos medical | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) | October 14, 2010 |
| K093258 | helix medical | BLOM-SINGER INDWELLING TEP OCCLUDER | March 3, 2010 |
| K090455 | atos medical | PROVOX VEGA, MODEL 8130-8135 | June 5, 2009 |
| K082206 | helix medical | BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-20 | September 4, 2008 |
| K043138 | atos medical | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 | November 22, 2004 |
| K022125 | atos medical | PROVOX FREEHANDS HME, MODEL 7710 | July 30, 2002 |
| K991587 | helix medical | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS | June 25, 1999 |
| K974132 | e. benson hood lab | VOICE MASTER PROSTHESIS | February 25, 1998 |
| K971244 | atos medical | PROVOX 2 VOICE PROSTHESIS SYSTEM | June 6, 1997 |
| K945287 | helix medical | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE | December 9, 1994 |
| K945288 | helix medical | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE | December 2, 1994 |
| K940638 | atos medical | PROVOX(TM) VOICE PROSTHESIS | June 22, 1994 |
| K932120 | helix medical | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES | April 15, 1994 |
| K932163 | helix medical | BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET | December 15, 1993 |
| K930105 | helix medical | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. | May 17, 1993 |
| K920090 | helix medical | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET | September 10, 1992 |
| K912486 | exmoor plastics | SINGH SPEECH SYSTEM (SERIES 'SSS') | September 4, 1992 |