510(k) K081681 ยท MLZ Vitrectomy, Instrument Cutter
VITRECTOMY CUTTER AND ACCESSORIES
| Applicant | Advanced Medical Optics, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Oct 8, 2008 |
| Received | Jun 17, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K081681
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2018 | Johnson & Johnson Surgical Vision Inc Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc.,
The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from Terminated |
MLZ | None listed |
| May 16, 2017 | Abbott Medical Optics Inc. (AMO) AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use. Terminated |
MLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.