FDA 510(k)

BIVONA NASAL TURBINATE STENT

K-Number: K935053 · 1994-07-01

Decision Date1994-07-01

Product CodeLYA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

BIVONA NASAL TURBINATE STENT is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1994-07-01 under 510(k) number K935053. 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 BIVONA NASAL TURBINATE STENT?

BIVONA NASAL TURBINATE STENT is a medical device that received FDA 510(k) clearance on 1994-07-01. The listed applicant is Bivona Medical Technologies. The 510(k) number is K935053.

When did BIVONA NASAL TURBINATE STENT receive FDA 510(k) clearance?

BIVONA NASAL TURBINATE STENT received FDA 510(k) clearance on 1994-07-01, under 510(k) number K935053.

Who is the listed applicant for BIVONA NASAL TURBINATE STENT?

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

What is the FDA product code for BIVONA NASAL TURBINATE STENT?

The FDA product code for BIVONA NASAL TURBINATE STENT is LYA.

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Other records listing Bivona Medical Technologies as applicant

K952700SUPERSLICK K942025BURGET NASAL STENT K944178BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES K933398BIVONA ILLUMINATED ENDOTRACHEAL TUBE K931749BIVONA(R) ICU ENDOTRACHEAL TUBE K922665BIVONA HYPERFLEX TRACHEOSTOMY TUBE

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Related Devices (Code: LYA)

K243655TurbAlignSpirair, Inc.K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.K213153SPIWay Endonasal Access GuideSpiway, LLC K202623Novapak Nasal Sinus Packing and StentMedtronic Xomed K181696ChitoZolveGyrus 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.