# K181696: ChitoZolve

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Nov 30, 2018 after 156 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.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122494: Posisep and Posisep X Hemostat Dressing/Intranasal Splint, Hemostasis, LLC (2013) Summary page 5.

## Indications for use
Indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to: - Separate tissue or structures compromised by surgical trauma - Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity - Help control minimal bleeding following surgery or trauma - Help control minimal bleeding following surgery or nasal trauma by tamponade effect blood absorption and platelet aggregation - Act as an adjunct to aid in the natural healing process Indicated for use as a nasal hemostat to treat epistaxis. Intended for use under the direction of a licensed healthcare provider.

Source page: https://510kreport.com/device/K181696
Methodology: https://510kreport.com/methodology