# K172179: Chitogel Endoscopic Sinus Surgery Kit

- Pathway: 510(k) (Traditional)
- Applicant: Chitogel, Ltd.
- Decided: Oct 17, 2017 after 90 days
- Product code: LYA (Splint, Intranasal Septal)
- Device class: 1
- Regulation: 21 CFR 874.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896068 (1990). 42 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141704: Novashield Injectable Nasal Packing and Stent, Medtronic, Inc. (2014) Summary page 4.

## Most influential descendants
- K230142: Epi-Stop Nasal Gel/epistaxis pack (2023), 0 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K172179
Methodology: https://510kreport.com/methodology