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FDA 510(k)

ADVACOAT SINUS GEL AND STENT

K-Number: K070496 · 2007-03-15

ApplicantCarbylan Biosurgery
Decision Date2007-03-15
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ADVACOAT SINUS GEL AND STENT is the device name listed in this FDA 510(k) record. The listed applicant is Carbylan Biosurgery. It received FDA 510(k) clearance on 2007-03-15 under 510(k) number K070496. 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 ADVACOAT SINUS GEL AND STENT?

ADVACOAT SINUS GEL AND STENT is a medical device that received FDA 510(k) clearance on 2007-03-15. The listed applicant is Carbylan Biosurgery. The 510(k) number is K070496.

When did ADVACOAT SINUS GEL AND STENT receive FDA 510(k) clearance?

ADVACOAT SINUS GEL AND STENT received FDA 510(k) clearance on 2007-03-15, under 510(k) number K070496.

Who is the listed applicant for ADVACOAT SINUS GEL AND STENT?

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

What is the FDA product code for ADVACOAT SINUS GEL AND STENT?

The FDA product code for ADVACOAT SINUS GEL AND STENT 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 Carbylan Biosurgery 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.

K063308ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200

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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