# K230142: Epi-Stop Nasal Gel/epistaxis pack

- Pathway: 510(k) (Traditional)
- Applicant: Biomed Ent, Inc.
- Decided: Mar 22, 2023 after 63 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: 9 generations back to K896068 (1990). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172179: Chitogel Endoscopic Sinus Surgery Kit, Chitogel, Ltd. (2017) Summary page 4.

## Indications for use
Epi-Stop™ Nasal Gel/Epistaxis Pack is a sterile, single use device indicated for use in patients suffering from anterior epistaxis to: - Help control minimal bleeding following trauma by barrier function, blood absorption and platelet aggregation; - Act as an adjunct to aid in the natural healing process. Epi-Stop™ Nasal Gel/Epistaxis Pack is indicated for use as a nasal packing to treat anterior epistaxis. Epi-Stop™ Nasal Gel/Epistaxis Pack is intended for use under the direction of a licensed healthcare provider.

Source page: https://510kreport.com/device/K230142
Methodology: https://510kreport.com/methodology