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FDA 510(k)

MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)

K-Number: K130354 · 2013-05-29

ApplicantEntrigue Surgical, Inc.
Decision Date2013-05-29
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) 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 2013-05-29 under 510(k) number K130354. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)?

MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) is a medical device that received FDA 510(k) clearance on 2013-05-29. The listed applicant is Entrigue Surgical, Inc.. The 510(k) number is K130354.

When did MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) receive FDA 510(k) clearance?

MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) received FDA 510(k) clearance on 2013-05-29, under 510(k) number K130354.

Who is the listed applicant for MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)?

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 MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)?

The FDA product code for MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) is LYA.

Related Clinical Trials

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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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.

K121351SINUS DILATION SYSTEMK082750ENTACT SEPTAL STAPLER, MODEL 610-00100K072470BIOELAST 5-0 SUTURE, MODEL 500100

Related Devices (Code: LYA)

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.

K243655TurbAlignSpirair, Inc.K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.K213153SPIWay Endonasal Access GuideSpiway, LLCK202623Novapak Nasal Sinus Packing and StentMedtronic XomedK181696ChitoZolveGyrus Acmi, Inc.K180141SPIWay Endonasal Access GuideSpiway, 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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