Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AHMED GLAUCOMA VALVE, MODEL S3

K-Number: K980657 · 1998-04-20

ApplicantNew World Medical, Inc.
Decision Date1998-04-20
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AHMED GLAUCOMA VALVE, MODEL S3 is the device name listed in this FDA 510(k) record. The listed applicant is New World Medical, Inc.. It received FDA 510(k) clearance on 1998-04-20 under 510(k) number K980657. 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 S3?

AHMED GLAUCOMA VALVE, MODEL S3 is a medical device that received FDA 510(k) clearance on 1998-04-20. The listed applicant is New World Medical, Inc.. The 510(k) number is K980657.

When did AHMED GLAUCOMA VALVE, MODEL S3 receive FDA 510(k) clearance?

AHMED GLAUCOMA VALVE, MODEL S3 received FDA 510(k) clearance on 1998-04-20, under 510(k) number K980657.

Who is the listed applicant for AHMED GLAUCOMA VALVE, MODEL S3?

The FDA 510(k) record lists New World Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AHMED GLAUCOMA VALVE, MODEL S3?

The FDA product code for AHMED GLAUCOMA VALVE, MODEL S3 is KYF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing New World Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243503VIA360™ Surgical SystemK220891Kahook Dual Blade Glide (KDB Glide)K231051Ahmed® Glaucoma Valve Model FP8K230975Ahmed® Glaucoma Valve Model FP7K211680Streamline Surgical SystemK182518AHMED ClearPath Glaucoma Drainage Device

View all 12 devices →

Related Devices (Code: KYF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc.K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc.K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos CorporationK182518AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc.K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc.K161457XEN Glaucoma Treatment SystemAllergan, 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.

↑