LARYNGEAL AUGMENTATION IMPLANT
FDA 510(k) clearance K033398 · decided 2003-12-12
Clearance details
- K-number
- K033398
- Device name
- LARYNGEAL AUGMENTATION IMPLANT
- Applicant
- Bioform, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-10-24
- Decision date
- 2003-12-12
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- MIX
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- San Mateo, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Silk Voice (SMI-04) (K240919) | Sofregen Medical | 2024-05-03 |
| Silk Voice (K180631) | Sofregen Medical, Inc. | 2018-11-08 |
| Renu Gel (K150400) | Cytophil, Inc. | 2015-04-06 |
| CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT (K121795) | Cytophil, Inc. | 2013-02-22 |
| VF LIQUIGEL (K083783) | Coapt Systems, Inc. | 2009-09-11 |
| VOCALIS AND VOCALIS SM (K081816) | Cytophil, Inc. | 2009-01-05 |
| VOCALIS GEL (K081815) | Cytophil, Inc. | 2009-01-05 |
| MODIFICATION TO VF GEL PLUS (K080956) | Coapt Systems, Inc. | 2008-04-25 |
| VF GEL PLUS (K071663) | Coapt Systems, Inc. | 2008-02-15 |
| RADIESSE LARYNGEAL IMPLANT (K070090) | Bioform Medical, Inc. | 2007-03-01 |
| JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT (K060815) | Bioform Medical, Inc. | 2006-04-18 |
| LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT (K011554) | Biomet, Inc. | 2001-06-26 |
Recalls involving this device
No recalls on record reference this clearance.