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FDA 510(k)

Ahmed Glaucoma Valve

K-Number: K162060 · 2016-10-24

ApplicantNew World Medical, Inc.
Decision Date2016-10-24
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Ahmed Glaucoma Valve is a medical device manufactured by New World Medical, Inc.. It received FDA 510(k) clearance on 2016-10-24 under approval number K162060. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ahmed Glaucoma Valve?

Ahmed Glaucoma Valve is a medical device that received FDA 510(k) clearance on 2016-10-24. It is manufactured by New World Medical, Inc.. The 510(k) number is K162060.

When was Ahmed Glaucoma Valve approved by the FDA?

Ahmed Glaucoma Valve received FDA 510(k) clearance on 2016-10-24, under approval number K162060.

What company makes Ahmed Glaucoma Valve?

Ahmed Glaucoma Valve is manufactured by New World Medical, Inc..

What is the FDA product code for Ahmed Glaucoma Valve?

The FDA product code for Ahmed Glaucoma Valve is KYF.

Related Clinical Trials

NCT04542616 Baerveldt 350 vs Ahmed ClearPath 250 for the Treatment of Glaucoma COMPLETED

Other Devices by New World Medical, Inc.

K171451Ahmed Glaucoma Valve Model FP8 K182518AHMED ClearPath Glaucoma Drainage Device K211680Streamline Surgical System K230975Ahmed® Glaucoma Valve Model FP7 K231051Ahmed® Glaucoma Valve Model FP8 K220891Kahook Dual Blade Glide (KDB Glide)

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Related Devices (Code: KYF)

K161457XEN Glaucoma Treatment SystemAllergan, Inc. K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc. K182518AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc. K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc. K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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