Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K213467
EVA NEXUS Ophthalmic Surgical System · D.O.R.C. Dutch Ophthalmic Research Center (International) · decided 2022-06-14 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| EVA Nexus™ Irrigation Tubing | 9110.IRR01-00 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE HQF | 08717872036502 |
| EVA NEXUS™ Combined 23G TDC Pack | 9310.23G02 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE | 08717872032856 |
| EVA NEXUS™ Posterior 23G TDC Pack | 9310.23G01-00 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 08717872034737 |
| EVA NEXUS™ Combined 27G TDC Pack | 9310.27G02 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE | 08717872032917 |
| EVA NEXUS™ Infusion Giving Set | 9110.INP01-00 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE HQF | 08717872036496 |
| EVA Nexus™ Aux. Aspiration Tubing | 9110.AAS01-00 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE HQF | 08717872036618 |
| EVA NEXUS™ Posterior 23G TDC Pack | 9311.23G01-00 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 08717872035307 |
| EVA NEXUS™ Posterior 25G TDC Pack | 9311.25G01 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 08717872035116 |
| EVA NEXUS™ Posterior 25G TDC Pack | 9310.25G01 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 08717872032887 |
| EVA NEXUS™ Combined 27G TDC Pack | 9310.27G02-00 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE | 08717872034782 |
| EVA NEXUS™ cartridge with 0,5 L collection bag | 9100.CAR01 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE HQF | 08717872032788 |
| EVA NEXUS™ Combined 25G TDC Pack | 9311.25G02-00 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 08717872035345 |
| EVA NEXUS™, Phaco vitrectomy system | 9000.COMU1 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE | 08717872034423 |
| EVA NEXUSTM Custom Phaco Pack 1.8mm 45 (Angled) | 9545.18AF1 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE | 08717872034348 |
| EVA Nexus™ Infusion Tubing | 9110.INF01 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE HQF | 08717872032993 |
| EVA NEXUS™, Phaco vitrectomy system including laser with DORC connector | 9000.COMU2 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE HQF | 08717872034430 |
| EVA NEXUSTM Custom Phaco Pack 2.4mm 30 (Straight) | 9530.24SF1 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE | 08717872034331 |
| EVA NEXUSTM Custom Phaco Pack 1.8mm 30 (Angled) | 9530.18AF1 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE | 08717872034294 |
| Directional Laser Probe with Alcon / Lumenis connector.(27 gauge / 0.4 mm) | 7227.ALC | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQF | 08717872031897 |
| EVA NEXUS™ cartridge with 0,5 L collection bag | 9100.CAR01-00 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE HQF | 08717872036625 |
| Directional Laser Probe with DORC connector.(25 gauge / 0.5 mm) | 7225.DORC | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQF | 08717872014968 |
| EVA NEXUSTM Custom Phaco Pack 2.2mm 30 (Straight) | 9530.22SF1 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE | 08717872034324 |
| EVA Nexus™ Infusion and Aux. Aspiration Tubing | 9110.IAD02 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE HQF | 08717872032962 |
| EVA Nexus™ Aux. Aspiration Tubing | 9110.AAS01 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQC HQE HQF | 08717872032979 |
| EVA NEXUS™ Combined 27G TDC Pack | 9311.27G02-00 | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | HQE | 08717872035352 |