FDA 510(k)

Chitogel Endoscopic Sinus Surgery Kit

K-Number: K172179 · 2017-10-17

Decision Date2017-10-17

Product CodeLYA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Chitogel Endoscopic Sinus Surgery Kit is the device name listed in this FDA 510(k) record. The listed applicant is Chitogel, Ltd.. It received FDA 510(k) clearance on 2017-10-17 under 510(k) 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. The listed applicant is Chitogel, Ltd.. The 510(k) number is K172179.

When did Chitogel Endoscopic Sinus Surgery Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Chitogel Endoscopic Sinus Surgery Kit?

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

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 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, LLC K202623Novapak Nasal Sinus Packing and StentMedtronic Xomed K181696ChitoZolveGyrus Acmi, Inc.K180141SPIWay Endonasal Access GuideSpiway, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.