Modification to VF Gel Plus
FDA 510(k) K080956 · Coapt Systems, Inc.
510(k) numberK080956
Submission
- Device name
- Modification to VF Gel Plus
- Applicant
- Coapt Systems, Inc.
Palo Alto, CA, US - Received
- April 3, 2008
- Decision date
- April 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MIX – System, Vocal Cord Medialization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code MIX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240919 | Silk Voice (SMI-04)MIX · Special | Sofregen Medical | 05/03/2024SE |
| K180631 | Silk VoiceMIX · Traditional | Sofregen Medical, Inc. | 11/08/2018SE |
| K150400 | Renu GelMIX · Special | Cytophil, Inc. | 04/06/2015SE |
| K121795 | Calcium Hydroxylapatite Vocal Fold ImplantMIX · Traditional | Cytophil, Inc. | 02/22/2013SE |
| K083783 | VF LiquigelMIX · Traditional | Coapt Systems, Inc. | 09/11/2009SE |
| K081816 | Vocalis and Vocalis SMMIX · Traditional | Cytophil, Inc. | 01/05/2009SE |
| K081815 | Vocalis GelMIX · Traditional | Cytophil, Inc. | 01/05/2009SE |
| K071663 | VF Gel PlusMIX · Traditional | Coapt Systems, Inc. | 02/15/2008SE |
| K070090 | Radiesse Laryngeal ImplantMIX · Special | Bioform Medical, Inc. | 03/01/2007SE |
| K060815 | Juliesse Injectable Laryngeal Augmentation ImplantMIX · Special | Bioform Medical, Inc. | 04/18/2006SE |
More from Bioform Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K083783 | VF LiquigelMIX · Traditional | 09/11/2009SE |
| K071663 | VF Gel PlusMIX · Traditional | 02/15/2008SE |
| K060249 | Ultratine ForeheadHWC · Traditional | 06/12/2006SE |
| K060248 | Ultratine TransblephHWC · Traditional | 06/12/2006SE |
| K060828 | Modification to Endotine RibbonGAM · Special | 04/19/2006SE |
| K051415 | Endotine RibbonGAM · Traditional | 06/23/2005SE |
| K050611 | Endotine RibbonGAM · Special | 04/06/2005SE |
| K042796 | Endotine Transbleph 3.0/3.5 DeviceHWC · Special | 11/05/2004SE |
| K041835 | Endotine Midface B 4.5 DeviceHWC · Traditional | 09/28/2004SE |
| K042078 | Endotine Forehead Triple DeviceHWC · Special | 08/27/2004SE |
Questions and answers
When was Modification to VF Gel Plus cleared by the FDA?
Modification to VF Gel Plus (K080956) received a 510(k) decision of Substantially Equivalent on April 25, 2008, 22 days after the submission was received.
What is the product code of K080956?
The FDA product code is MIX – System, Vocal Cord Medialization, a Class II (moderate risk) device regulated under 21 CFR 874.3620.