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510(k) Data Aggregation
K Number
K172179Device Name
Chitogel Endoscopic Sinus Surgery Kit
Manufacturer
Chitogel Ltd
Date Cleared
2017-10-17
(90 days)
Product Code
LYA
Regulation Number
874.4780Why did this record match?
Applicant Name (Manufacturer) :
Chitogel Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chitogel Endoscopic Sinus Surgery Kit is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to:
- Separate tissue or structures compromised by surgical trauma
- Separate and prevent adhesions between mucosal surfaces in the nasal cavity and minimize ostial stenosis following endoscopic sinus surgery
- Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation
- Act as an adjunct to aid in the natural healing process
The Chitogel Endoscopic Sinus Surgery Kit is indicated for use as a nasal packing to treat epistaxis.
Device Description
The Chitogel Endoscopic Sinus Surgery Kit consists of the following components:
- Sealed vial containing 300mg Dextran Aldehyde Powder
- Sealed vial containing 10ml Sodium Phosphate Buffer Solution
- Sealed vial containing 10ml Chitosan Succinaamide Solution
- 12cc control syringe
- Fluid dispensing connector
- Two (2) mixing cannulae
- Malleable cannula
The Chitogel Endoscopic Sinus Surgery Kit is used during nasal surgery. The components in the Chitogel Kit are mixed by the physician using the syringe and cannulae provided. The pre- measured components mix to form the biodegradable gel. Once the components are mixed and create the gel, the physician applies the gel to the target area using the malleable cannula and thereby creating a nasal packing.
All components are provide sterile and are for single use only.
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