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FDA 510(k)

MICROMEDICS SPHENOID SINUS STENT

K-Number: K050340 · 2005-04-27

ApplicantMicromedics, Inc.
Decision Date2005-04-27
Product CodeKAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROMEDICS SPHENOID SINUS STENT is the device name listed in this FDA 510(k) record. The listed applicant is Micromedics, Inc.. It received FDA 510(k) clearance on 2005-04-27 under 510(k) number K050340. The device is classified under product code KAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROMEDICS SPHENOID SINUS STENT?

MICROMEDICS SPHENOID SINUS STENT is a medical device that received FDA 510(k) clearance on 2005-04-27. The listed applicant is Micromedics, Inc.. The 510(k) number is K050340.

When did MICROMEDICS SPHENOID SINUS STENT receive FDA 510(k) clearance?

MICROMEDICS SPHENOID SINUS STENT received FDA 510(k) clearance on 2005-04-27, under 510(k) number K050340.

Who is the listed applicant for MICROMEDICS SPHENOID SINUS STENT?

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

What is the FDA product code for MICROMEDICS SPHENOID SINUS STENT?

The FDA product code for MICROMEDICS SPHENOID SINUS STENT is KAM.

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Other records listing Micromedics, Inc. as applicant

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Related Devices (Code: KAM)

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.

K110687RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)Acclarent, Inc.K093594MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACERAcclarent, Inc.K083574RELIEVA STRATUS MICROFLOW SPACERAcclarent, Inc.K072891SINUS SPACERAcclarent, Inc.K073041RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETERAcclarent, Inc.K071845RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100AAcclarent, 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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