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

FDA 510(k)

Chitogel Endoscopic Sinus Surgery Kit

K-Number: K172179 · 2017-10-17

ApplicantChitogel, Ltd.
Decision Date2017-10-17
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Chitogel Endoscopic Sinus Surgery Kit is a medical device manufactured by Chitogel, Ltd.. It received FDA 510(k) clearance on 2017-10-17 under approval number K172179. 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 Chitogel Endoscopic Sinus Surgery Kit?

Chitogel Endoscopic Sinus Surgery Kit is a medical device that received FDA 510(k) clearance on 2017-10-17. It is manufactured by Chitogel, Ltd.. The 510(k) number is K172179.

When was Chitogel Endoscopic Sinus Surgery Kit approved by the FDA?

Chitogel Endoscopic Sinus Surgery Kit received FDA 510(k) clearance on 2017-10-17, under approval number K172179.

What company makes Chitogel Endoscopic Sinus Surgery Kit?

Chitogel Endoscopic Sinus Surgery Kit is manufactured by Chitogel, Ltd..

What is the FDA product code for Chitogel Endoscopic Sinus Surgery Kit?

The FDA product code for Chitogel Endoscopic Sinus Surgery Kit is LYA.

Related Clinical Trials

NCT07368361 Th Study Wants to Compare the Best Technique for Sinus Operation in CRSWNP RECRUITING NCT07557589 Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months RECRUITING NCT07606430 Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07035431 Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area RECRUITING

Related Devices (Code: LYA)

K153686SPIWay Endonasal Access GuideSpiway, LLC K170913Composite Removable Sinus Stent SystemSts Medical K181696ChitoZolveGyrus Acmi, Inc. K180141SPIWay Endonasal Access GuideSpiway, LLC K202623Novapak Nasal Sinus Packing and StentMedtronic Xomed K213153SPIWay 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.

↑