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FDA 510(k)

AHMED ClearPath Glaucoma Drainage Device

K-Number: K182518 · 2019-01-18

ApplicantNew World Medical, Inc.
Decision Date2019-01-18
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AHMED ClearPath Glaucoma Drainage Device is a medical device manufactured by New World Medical, Inc.. It received FDA 510(k) clearance on 2019-01-18 under approval number K182518. 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 ClearPath Glaucoma Drainage Device?

AHMED ClearPath Glaucoma Drainage Device is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by New World Medical, Inc.. The 510(k) number is K182518.

When was AHMED ClearPath Glaucoma Drainage Device approved by the FDA?

AHMED ClearPath Glaucoma Drainage Device received FDA 510(k) clearance on 2019-01-18, under approval number K182518.

What company makes AHMED ClearPath Glaucoma Drainage Device?

AHMED ClearPath Glaucoma Drainage Device is manufactured by New World Medical, Inc..

What is the FDA product code for AHMED ClearPath Glaucoma Drainage Device?

The FDA product code for AHMED ClearPath Glaucoma Drainage Device is KYF.

Related Clinical Trials

NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT07589270 Direct Selective Laser Trabeculoplasty (DSLT) for Patients With Glaucoma or Ocular Hypertension Previously Treated With SLT NOT_YET_RECRUITING NCT06822738 A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma RECRUITING NCT07494812 Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials NOT_YET_RECRUITING NCT04024293 Intraocular Pressure Measured by a Novel Sensing Contact Lens Versus Tonometry RECRUITING NCT05821855 A Study to Evaluate Adverse Events and Change in Disease Activity With the XEN45 Glaucoma Treatment System Implantation In Adult Participants With Open-Angle Glaucoma in China ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 37466494 The Development of a SIBS Shunt to Treat Glaucoma. Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics (2023)

Other Devices by New World Medical, Inc.

K162060Ahmed Glaucoma Valve K171451Ahmed Glaucoma Valve Model FP8 K211680Streamline Surgical System K230975Ahmed® Glaucoma Valve Model FP7 K231051Ahmed® Glaucoma Valve Model FP8 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. 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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