Implant, Eye Valve
FDA product code KYF · Class II (moderate risk) · 21 CFR 886.3920 · Ophthalmic
25510(k) clearances
0PMA approvals
2recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231051 | Ahmed® Glaucoma Valve Model FP8KYF · Special | New World Medical, Inc. | 05/12/2023SE |
| K230975 | Ahmed® Glaucoma Valve Model FP7KYF · Special | New World Medical, Inc. | 05/12/2023SE |
| K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3KYF · Traditional | Glaukos Corporation | 08/02/2022SE |
| K182518 | AHMED ClearPath Glaucoma Drainage DeviceKYF · Traditional | New World Medical, Inc. | 01/18/2019SE |
| K171451 | Ahmed Glaucoma Valve Model FP8KYF · Traditional | New World Medical, Inc. | 08/08/2017SE |
| K161457 | XEN Glaucoma Treatment SystemKYF · Traditional | Allergan, Inc. | 11/21/2016SE |
| K162060 | Ahmed Glaucoma ValveKYF · Traditional | New World Medical, Inc. | 10/24/2016SE |
| K152996 | Molteno3 Glaucoma ImplantKYF · Traditional | Innovative Ophthalmic Products, Inc. (Iop) | 12/17/2015SE |
| K062252 | MOLTENO3KYF · Traditional | Iop, Inc. | 09/27/2006SE |
| K060644 | Ahmed Glaucoma Valve, Model M4KYF · Traditional | New World Medical, Inc. | 09/18/2006SE |
| K030350 | Express Mini Glaucoma ShuntKYF · Abbreviated | Optonol, Ltd. | 03/13/2003SE |
| K012852 | Ex-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS VersionsKYF · Traditional | Optonol, Ltd. | 03/26/2002SE |
| K991072 | Ahmed Glaucoma Valve ImplantKYF · Traditional | New World Medical, Inc. | 07/13/1999SE |
| K980657 | Ahmed Glaucoma Valve, Model S3KYF · Traditional | New World Medical, Inc. | 04/20/1998SE |
| K955455 | Baervelt Pars Plana Glaucoma ImplantKYF · Traditional | Pharmacia Iovision, Inc. | 02/18/1997SE |
| K925636 | Ahmed Glaucoma Valve ImplantKYF · Traditional | New World Medical, Inc. | 11/12/1993SE |
| K905703 | Krupin Eye Valve with DiskKYF · Traditional | Hood Laboratories | 03/15/1991SE |
| K902296 | Trabeculo-Suprachoroidal ShuntKYF · Traditional | Visionex, Inc. | 03/14/1991SE |
| K905129 | Baerveldt Glaucoma ImplantKYF · Traditional | Wright Medical Corp. | 02/11/1991SE |
| K903462 | Optimed Glaucoma Pressure RegulatorKYF · Traditional | Optimed, Inc. | 10/16/1990SE |
| K902489 | Modified Molteno(Tm) ImplantsKYF · Traditional | Iop, Inc. | 08/14/1990SE |
| K890598 | Molteno ImplantKYF · Traditional | Iop, Inc. | 02/27/1989SE |
| K885125 | Krupin Eye Valve W/Scleral BuckleKYF · Traditional | Hood Laboratories | 01/24/1989SE |
| K875099 | Molteno Valve SetonKYF · Traditional | Staar Surgical Co. | 03/30/1988SE |
| K840204 | White Ocular Pressure Relief DeviceKYF · Traditional | Precision-Cosmet Co., Inc. | 02/15/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0598-2020 Class II | XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other…Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on… | Allergan PLC | 10/30/2019Open, Classified |
| Z-1252-2016 Class II | Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175)…Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package… | Innovative Ophthalmic Products, Inc | 02/22/2016Terminated |