Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K063308 · 2006-12-04

ApplicantCarbylan Biosurgery
Decision Date2006-12-04
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 is the device name listed in this FDA 510(k) record. The listed applicant is Carbylan Biosurgery. It received FDA 510(k) clearance on 2006-12-04 under 510(k) number K063308. 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, MODEL 9100, ADVA SINUS STENT, MODEL 9200?

ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 is a medical device that received FDA 510(k) clearance on 2006-12-04. The listed applicant is Carbylan Biosurgery. The 510(k) number is K063308.

When did ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 receive FDA 510(k) clearance?

ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 received FDA 510(k) clearance on 2006-12-04, under 510(k) number K063308.

Who is the listed applicant for ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200?

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, MODEL 9100, ADVA SINUS STENT, MODEL 9200?

The FDA product code for ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K070496ADVACOAT SINUS GEL AND STENT

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.

↑