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FDA 510(k)

RELIENT NAVIGATION DEVICE

K-Number: K060974 · 2006-05-05

ApplicantAcclarent, Inc.
Decision Date2006-05-05
Product CodeKAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RELIENT NAVIGATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2006-05-05 under 510(k) number K060974. 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 RELIENT NAVIGATION DEVICE?

RELIENT NAVIGATION DEVICE is a medical device that received FDA 510(k) clearance on 2006-05-05. The listed applicant is Acclarent, Inc.. The 510(k) number is K060974.

When did RELIENT NAVIGATION DEVICE receive FDA 510(k) clearance?

RELIENT NAVIGATION DEVICE received FDA 510(k) clearance on 2006-05-05, under 510(k) number K060974.

Who is the listed applicant for RELIENT NAVIGATION DEVICE?

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 RELIENT NAVIGATION DEVICE?

The FDA product code for RELIENT NAVIGATION DEVICE 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.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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