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FDA 510(k)

MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER

K-Number: K093594 · 2010-03-03

ApplicantAcclarent, Inc.
Decision Date2010-03-03
Product CodeKAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO RELIEVA STRATUS MICROFLOW 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 2010-03-03 under 510(k) number K093594. 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 MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER?

MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER is a medical device that received FDA 510(k) clearance on 2010-03-03. The listed applicant is Acclarent, Inc.. The 510(k) number is K093594.

When did MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER receive FDA 510(k) clearance?

MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER received FDA 510(k) clearance on 2010-03-03, under 510(k) number K093594.

Who is the listed applicant for MODIFICATION TO RELIEVA STRATUS MICROFLOW 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 MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER?

The FDA product code for MODIFICATION TO RELIEVA STRATUS MICROFLOW 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.

K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemK230742ACCLARENT AERA Eustachian Tube Dilation SystemK231862TruDi® Navigation System V3 (FG-2000-00)K221037TruDi Shaver BladeK201115Next Generation Balloon Dilation SystemK201174TruDi Curette

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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.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.K062458ETHMOID SINUS SPACERAcclarent, 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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