VOCOM IMPLANT- 8MM
FDA 510(k) clearance K000533 · decided 2000-03-01
Clearance details
- K-number
- K000533
- Device name
- VOCOM IMPLANT- 8MM
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-02-17
- Decision date
- 2000-03-01
- Days to decision
- 13 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
- Bartlett, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Smith & Nephew
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| LARYNGEAL AUGMENTATION IMPLANT (K033398) | Bioform, Inc. | 2003-12-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |