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FDA 510(k)

SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT

K-Number: K131709 · 2013-10-04

ApplicantArthrocare Corp.
Decision Date2013-10-04
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2013-10-04 under 510(k) number K131709. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT?

SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT is a medical device that received FDA 510(k) clearance on 2013-10-04. The listed applicant is Arthrocare Corp.. The 510(k) number is K131709.

When did SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT receive FDA 510(k) clearance?

SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT received FDA 510(k) clearance on 2013-10-04, under 510(k) number K131709.

Who is the listed applicant for SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT?

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

What is the FDA product code for SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT?

The FDA product code for SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT is LRC.

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Other records listing Arthrocare Corp. as applicant

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Related Devices (Code: LRC)

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.

K230258BB 8 Sinus Dilation KitExcelent, Inc.K212774VenSure LightGuideIntersect Ent.K201398SINUSPRIME Dilation SystemStryker EntK201115Next Generation Balloon Dilation SystemAcclarent, Inc.K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbHK181546Dillard Nasal Balloon CatheterIntuit 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.

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