Laryngeal Augmentation Implant
FDA 510(k) K033398 · Bioform, Inc.
510(k) numberK033398
Submission
- Device name
- Laryngeal Augmentation Implant
- Applicant
- Bioform, Inc.
San Mateo, CA, US - Received
- October 24, 2003
- Decision date
- December 12, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K080956 | Modification to VF Gel PlusMIX · Special | Coapt Systems, Inc. | 04/25/2008SE |
| K071663 | VF Gel PlusMIX · Traditional | Coapt Systems, Inc. | 02/15/2008SE |
| K070090 | Radiesse Laryngeal ImplantMIX · Special | Bioform Medical, Inc. | 03/01/2007SE |
More from Bioform Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030682 | Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3LYC · Traditional | 06/27/2003SE |
| K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1KHJ · Traditional | 01/09/2002SE |
| K012955 | Coaptite Tissue Marker and Coaptite FN Tissue MarkerNEU · Traditional | 10/22/2001SE |
Questions and answers
When was Laryngeal Augmentation Implant cleared by the FDA?
Laryngeal Augmentation Implant (K033398) received a 510(k) decision of Substantially Equivalent on December 12, 2003, 49 days after the submission was received.
What is the product code of K033398?
The FDA product code is MIX – System, Vocal Cord Medialization, a Class II (moderate risk) device regulated under 21 CFR 874.3620.