510(k) K121675 ยท HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
VERSAVIT
| Applicant | Synergetics, Inc., O' Fallon MO, US |
| Decision | Substantially Equivalent, Jun 21, 2012 |
| Received | Jun 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121675
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2016 | Synergetics Inc 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system. Terminated |
HQE | None listed |
| Oct 18, 2016 | Synergetics Inc 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system. Terminated |
HQE | None listed |
| Oct 18, 2016 | Synergetics Inc 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system. Terminated |
HQE | None listed |
| Oct 18, 2016 | Synergetics Inc 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged in a Tyvek/Mylar double pouch configuration. Terminated |
HQE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.