MIX — System, Vocal Cord Medialization Class II
FDA product code MIX covers "System, Vocal Cord Medialization", a Class II medical device regulated under 21 CFR 874.3620. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MIX
- Device Class
- Class II
- Regulation Number
- 874.3620
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240919 | sofregen medical | Silk Voice (SMI-04) | May 3, 2024 |
| K180631 | sofregen medical | Silk Voice | November 8, 2018 |
| K150400 | cytophil | Renu Gel | April 6, 2015 |
| K121795 | cytophil | CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT | February 22, 2013 |
| K083783 | coapt systems | VF LIQUIGEL | September 11, 2009 |
| K081815 | cytophil | VOCALIS GEL | January 5, 2009 |
| K081816 | cytophil | VOCALIS AND VOCALIS SM | January 5, 2009 |
| K080956 | coapt systems | MODIFICATION TO VF GEL PLUS | April 25, 2008 |
| K071663 | coapt systems | VF GEL PLUS | February 15, 2008 |
| K070090 | bioform medical | RADIESSE LARYNGEAL IMPLANT | March 1, 2007 |
| K060815 | bioform medical | JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT | April 18, 2006 |
| K033398 | bioform | LARYNGEAL AUGMENTATION IMPLANT | December 12, 2003 |
| K011554 | biomet | LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT | June 26, 2001 |
| K001466 | smith and nephew | VOCOM SILICONE SYSTEM | July 26, 2000 |
| K000533 | smith and nephew | VOCOM IMPLANT- 8MM | March 1, 2000 |
| K983525 | w. l. gore and associates | GORE REVOX THYROPLASTY IMPLANT | December 10, 1998 |
| K972317 | boston medical products | MONTGOMERY THYROPLASTY IMPLANT SYSTEM | September 18, 1997 |