FDA.reportPublic FDA data

510(k) K231051

Device
Ahmed® Glaucoma Valve Model FP8
Applicant
New World Medical, Inc.
510(k) number
K231051
Product code
KYF
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-12
Date received
2023-04-13
Regulation
886.3920
Classification name
Implant, Eye Valve
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Victor Arellano
Address
19763 Edison Ct. Rancho Cucamonga CA US 91730 91730

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KYF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc.2023-05-12
K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation2022-08-02
K182518AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc.2019-01-18
K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc.2017-08-08
K161457XEN Glaucoma Treatment SystemAllergan, Inc.2016-11-21
K162060Ahmed Glaucoma ValveNew World Medical, Inc.2016-10-24
K152996Molteno3 Glaucoma ImplantInnovative Ophthalmic Products, Inc. (Iop)2015-12-17
K062252MOLTENO3Iop, Inc.2006-09-27
K060644AHMED GLAUCOMA VALVE, MODEL M4New World Medical, Inc.2006-09-18
K030350EXPRESS MINI GLAUCOMA SHUNTOptonol, Ltd.2003-03-13
K012852EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONSOptonol, Ltd.2002-03-26
K991072AHMED GLAUCOMA VALVE IMPLANTNew World Medical, Inc.1999-07-13
K980657AHMED GLAUCOMA VALVE, MODEL S3New World Medical, Inc.1998-04-20
K955455BAERVELT PARS PLANA GLAUCOMA IMPLANTPharmacia Iovision, Inc.1997-02-18
K925636AHMED GLAUCOMA VALVE IMPLANTNew World Medical, Inc.1993-11-12