Voyant Open Sealer-Divider Device
FDA 510(k) clearance K143517 · decided 2015-03-27
Clearance details
- K-number
- K143517
- Device name
- Voyant Open Sealer-Divider Device
- Applicant
- Applied Medical Resources
- Decision
- Substantially Equivalent
- Date received
- 2014-12-12
- Decision date
- 2015-03-27
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rancho Santa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open recall (Z-2769-2015) | Applied Medical Resources Corp | 2015-09-15 |