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FDA 510(k)

Ahmed® Glaucoma Valve Model FP8

K-Number: K231051 · 2023-05-12

ApplicantNew World Medical, Inc.
Decision Date2023-05-12
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Ahmed® Glaucoma Valve Model FP8 is a medical device manufactured by New World Medical, Inc.. It received FDA 510(k) clearance on 2023-05-12 under approval number K231051. 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 Model FP8?

Ahmed® Glaucoma Valve Model FP8 is a medical device that received FDA 510(k) clearance on 2023-05-12. It is manufactured by New World Medical, Inc.. The 510(k) number is K231051.

When was Ahmed® Glaucoma Valve Model FP8 approved by the FDA?

Ahmed® Glaucoma Valve Model FP8 received FDA 510(k) clearance on 2023-05-12, under approval number K231051.

What company makes Ahmed® Glaucoma Valve Model FP8?

Ahmed® Glaucoma Valve Model FP8 is manufactured by New World Medical, Inc..

What is the FDA product code for Ahmed® Glaucoma Valve Model FP8?

The FDA product code for Ahmed® Glaucoma Valve Model FP8 is KYF.

Related Clinical Trials

NCT05526560 Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve ACTIVE_NOT_RECRUITING NCT02088554 PERIGON Pivotal Trial ACTIVE_NOT_RECRUITING NCT04542616 Baerveldt 350 vs Ahmed ClearPath 250 for the Treatment of Glaucoma COMPLETED NCT07120048 Real World Data Collection on the INSPIRIS RESILIA Aortic Valve RECRUITING

Other Devices by New World Medical, Inc.

K162060Ahmed Glaucoma Valve K171451Ahmed Glaucoma Valve Model FP8 K182518AHMED ClearPath Glaucoma Drainage Device K211680Streamline Surgical System K230975Ahmed® Glaucoma Valve Model FP7 K220891Kahook Dual Blade Glide (KDB Glide)

View all 8 devices →

Related Devices (Code: KYF)

K161457XEN Glaucoma Treatment SystemAllergan, Inc. K162060Ahmed Glaucoma ValveNew World Medical, 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.

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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