FDA Product Code
FDA Product Code MIX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3620
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240919 | Silk Voice (SMI-04) | Sofregen Medical | 2024-05-03 | Special | PDF ↗ |
| K180631 | Silk Voice | Sofregen Medical, Inc. | 2018-11-08 | Traditional | PDF ↗ |
| K150400 | Renu Gel | Cytophil, Inc. | 2015-04-06 | Special | PDF ↗ |
| K121795 | CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT | Cytophil, Inc. | 2013-02-22 | Traditional | PDF ↗ |
| K083783 | VF LIQUIGEL | Coapt Systems, Inc. | 2009-09-11 | Traditional | PDF ↗ |
| K081815 | VOCALIS GEL | Cytophil, Inc. | 2009-01-05 | Traditional | PDF ↗ |
| K081816 | VOCALIS AND VOCALIS SM | Cytophil, Inc. | 2009-01-05 | Traditional | PDF ↗ |
| K080956 | MODIFICATION TO VF GEL PLUS | Coapt Systems, Inc. | 2008-04-25 | Special | PDF ↗ |
| K071663 | VF GEL PLUS | Coapt Systems, Inc. | 2008-02-15 | Traditional | PDF ↗ |
| K070090 | RADIESSE LARYNGEAL IMPLANT | Bioform Medical, Inc. | 2007-03-01 | Special | PDF ↗ |
| K060815 | JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT | Bioform Medical, Inc. | 2006-04-18 | Special | PDF ↗ |
| K033398 | LARYNGEAL AUGMENTATION IMPLANT | Bioform, Inc. | 2003-12-12 | Traditional | PDF ↗ |
| K011554 | LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT | Biomet, Inc. | 2001-06-26 | Traditional | PDF ↗ |
| K001466 | VOCOM SILICONE SYSTEM | Smith & Nephew, Inc. | 2000-07-26 | Traditional | PDF ↗ |
| K000533 | VOCOM IMPLANT- 8MM | Smith & Nephew, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K983525 | GORE REVOX THYROPLASTY IMPLANT | W. L. Gore & Associates, Inc. | 1998-12-10 | Traditional | PDF ↗ |
| K972317 | MONTGOMERY THYROPLASTY IMPLANT SYSTEM | Boston Medical Products, Inc. | 1997-09-18 | Traditional | PDF ↗ |
Product code MIX · Class II · Ear, Nose, Throat. Data: openFDA.