KYF · Implant, Eye Valve
Ophthalmic · 21 CFR 886.3920 · Class 2
Overview
| Product Code | KYF |
|---|---|
| Device Name | Implant, Eye Valve |
| Regulation | 21 CFR 886.3920 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| Implant | Yes |
Identification
An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.
Classification Rationale
Class II. The special controls for this device are FDA's:
Special Controls
*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and (3) “Aqueous Shunts—510(k) Submissions.”
Recent Cleared Devices (20 of 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231051 | Ahmed® Glaucoma Valve Model FP8 | New World Medical, Inc. | May 12, 2023 | SESE |
| K230975 | Ahmed® Glaucoma Valve Model FP7 | New World Medical, Inc. | May 12, 2023 | SESE |
| K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 | Glaukos Corporation | Aug 2, 2022 | SESE |
| K182518 | AHMED ClearPath Glaucoma Drainage Device | New World Medical, Inc. | Jan 18, 2019 | SESE |
| K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | Aug 8, 2017 | SESE |
| K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | Nov 21, 2016 | SESE |
| K162060 | Ahmed Glaucoma Valve | New World Medical, Inc. | Oct 24, 2016 | SESE |
| K152996 | Molteno3 Glaucoma Implant | Innovative Ophthalmic Products, Inc. (Iop) | Dec 17, 2015 | SESE |
| K062252 | MOLTENO3 | Iop, Inc. | Sep 27, 2006 | SESE |
| K060644 | AHMED GLAUCOMA VALVE, MODEL M4 | New World Medical, Inc. | Sep 18, 2006 | SESE |
| K030350 | EXPRESS MINI GLAUCOMA SHUNT | Optonol, Ltd. | Mar 13, 2003 | SESE |
| K012852 | EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS | Optonol, Ltd. | Mar 26, 2002 | SESE |
| K991072 | AHMED GLAUCOMA VALVE IMPLANT | New World Medical, Inc. | Jul 13, 1999 | SESE |
| K980657 | AHMED GLAUCOMA VALVE, MODEL S3 | New World Medical, Inc. | Apr 20, 1998 | SESE |
| K955455 | BAERVELT PARS PLANA GLAUCOMA IMPLANT | Pharmacia Iovision, Inc. | Feb 18, 1997 | SESE |
| K925636 | AHMED GLAUCOMA VALVE IMPLANT | New World Medical, Inc. | Nov 12, 1993 | SESE |
| K905703 | KRUPIN EYE VALVE WITH DISK | Hood Laboratories | Mar 15, 1991 | SESE |
| K902296 | TRABECULO-SUPRACHOROIDAL SHUNT | Visionex, Inc. | Mar 14, 1991 | SESE |
| K905129 | BAERVELDT GLAUCOMA IMPLANT | Wright Medical Corp. | Feb 11, 1991 | SESE |
| K903462 | OPTIMED GLAUCOMA PRESSURE REGULATOR | Optimed, Inc. | Oct 16, 1990 | SESE |
Top Applicants
- New World Medical, Inc. — 9 clearances
- Iop, Inc. — 3 clearances
- Hood Laboratories — 2 clearances
- Optonol, Ltd. — 2 clearances
- Allergan, Inc. — 1 clearance
