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

FDA 510(k)

GrayDuck Stent

K-Number: K183374 · 2019-02-26

ApplicantPoll Medical, LLC
Decision Date2019-02-26
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GrayDuck Stent is a medical device manufactured by Poll Medical, LLC. It received FDA 510(k) clearance on 2019-02-26 under approval number K183374. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GrayDuck Stent?

GrayDuck Stent is a medical device that received FDA 510(k) clearance on 2019-02-26. It is manufactured by Poll Medical, LLC. The 510(k) number is K183374.

When was GrayDuck Stent approved by the FDA?

GrayDuck Stent received FDA 510(k) clearance on 2019-02-26, under approval number K183374.

What company makes GrayDuck Stent?

GrayDuck Stent is manufactured by Poll Medical, LLC.

What is the FDA product code for GrayDuck Stent?

The FDA product code for GrayDuck Stent is IYE.

Related Devices (Code: IYE)

K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. K161400ImagingRing SystemMedphoton GmbH K162468ClearCheckRadformation K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC K162265CushionCast Moldable CushionsIzi Medical Products, LLC

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.

↑