510(k) K161457 ยท KYF Implant, Eye Valve
XEN Glaucoma Treatment System
| Applicant | Allergan, Inc., Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Nov 21, 2016 |
| Received | May 26, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161457
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2019 | Allergan PLC XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment. Open, Classified |
KYF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.