VITRECTOMY CUTTER AND ACCESSORIES— 510(k) K081681
Substantially EquivalentAdvanced Medical Optics, Inc.
FDA 510(k) clearance K081681 for VITRECTOMY CUTTER AND ACCESSORIES, Substantially Equivalent on 2008-10-08. Applicant: Advanced Medical Optics, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Medical Optics, Inc.
- Product code
- Code MLZ
- Device class
- Class 2
- Regulation
- 21 CFR 886.4150
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Santa Ana, CA, US
Recent devices under product code MLZ
view allMore clearances from Advanced Medical Optics, Inc.
view allAdverse events under product code MLZ
product code MLZ- Malfunction
- 692
- Total
- 692
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K081681
K-number listed on FDA's recall record- Z-1893-2019 — 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 the eye. It has been designed as a disposable (single use)
- Z-2096-2017 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081681.
Data sourced from openFDA. This site is unofficial and independent of the FDA.