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FDA 510(k)

SINUS DILATION SYSTEM

K-Number: K121351 · 2012-08-29

ApplicantEntrigue Surgical, Inc.
Decision Date2012-08-29
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SINUS DILATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Entrigue Surgical, Inc.. It received FDA 510(k) clearance on 2012-08-29 under 510(k) number K121351. 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?

SINUS DILATION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-08-29. The listed applicant is Entrigue Surgical, Inc.. The 510(k) number is K121351.

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

SINUS DILATION SYSTEM received FDA 510(k) clearance on 2012-08-29, under 510(k) number K121351.

Who is the listed applicant for SINUS DILATION SYSTEM?

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

What is the FDA product code for SINUS DILATION SYSTEM?

The FDA product code for SINUS DILATION SYSTEM is LRC.

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Other records listing Entrigue Surgical, 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.

K130354MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)K082750ENTACT SEPTAL STAPLER, MODEL 610-00100K072470BIOELAST 5-0 SUTURE, MODEL 500100

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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