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FDA 510(k)

ETHMOID SINUS SPACER

K-Number: K062458 · 2006-09-15

ApplicantAcclarent, Inc.
Decision Date2006-09-15
Product CodeKAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ETHMOID SINUS SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2006-09-15 under 510(k) number K062458. 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 ETHMOID SINUS SPACER?

ETHMOID SINUS SPACER is a medical device that received FDA 510(k) clearance on 2006-09-15. The listed applicant is Acclarent, Inc.. The 510(k) number is K062458.

When did ETHMOID SINUS SPACER receive FDA 510(k) clearance?

ETHMOID SINUS SPACER received FDA 510(k) clearance on 2006-09-15, under 510(k) number K062458.

Who is the listed applicant for ETHMOID SINUS SPACER?

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

What is the FDA product code for ETHMOID SINUS SPACER?

The FDA product code for ETHMOID SINUS SPACER is KAM.

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Other records listing Acclarent, 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.

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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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