VERSAVIT
FDA 510(k) clearance K121675 · decided 2012-06-21
Clearance details
- K-number
- K121675
- Device name
- VERSAVIT
- Applicant
- Synergetics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-06-06
- Decision date
- 2012-06-21
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- HQE
- Device class
- 2
- Regulation number
- 886.4150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- O' Fallon, MO, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged recall (Z-0119-2017) | Synergetics Inc | 2016-10-18 |
| 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025 recall (Z-0120-2017) | Synergetics Inc | 2016-10-18 |
| 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Numb recall (Z-0121-2017) | Synergetics Inc | 2016-10-18 |
| 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/My recall (Z-0122-2017) | Synergetics Inc | 2016-10-18 |