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Endoscopic Sinus Surgery Kit

CHITOGEL LIMITED · Model CSK-4 · UDI-DI 09400998100040

LYA Prescription

510(k) clearances

203

Adverse events (3 deaths)

Recalls

105

Facilities

Description

The Chitogel Endoscopic Sinus Surgery Kit consists of the following components: - Sealed vial containing 350mg Dextran Aldehyde Powder - Sealed vial containing 12ml Sodium Phosphate Buffer Solution - Sealed vial containing 12ml Chitosan Succinamide Solution - Fluid dispensing connector - Two (2) mixing cannulae - Malleable cannulae - Two (2) 20ml sterile luer lock syringe The Chitogel Endoscopic Sinus Surgery Kit is used during nasal surgery. The components in the Chitogel Kit are mixed by the physician using the two 20 ml sterile 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.

Recalls

Date	Firm	Reason
2022-07-27	GELITA MEDICAL GMBH	In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
2006-07-11	Porex Surgical, Inc.	Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.