# K984069: Entaxis Nasal Packing

- Pathway: 510(k) (Traditional)
- Applicant: Les Laboratorires Brothier, S.A.
- Decided: Jan 25, 1999 after 70 days
- Product code: EMX (Balloon, Epistaxis)
- Device class: 1
- Regulation: 21 CFR 874.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K821150 (1982). 5 ancestors in all.
37 later devices descend from it; 4 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905314: Algoderm Alginate Wound Dressing, Les Laboratorires Brothier, S.A. (1991) Summary page 2.
- K922540: Wound Dressing, Les Laboratorires Brothier, S.A. (1992) Summary page 2.
- K821150: NU-Gauze Sponge, Johnson & Johnson Professionals, Inc. (1982) Summary page 2.
- K973511: Kendall Curity Petrolatum Gauze, Kendall Healthcare Products Co. Div.Of Tyco Health (1997) Summary page 2.
- K920394: Merocel Epistacis Kit, Merocel Corp. (1993) Summary page 2.

## Most influential descendants
- K993362: Hylasine (2000), 35 descendants of its own
- K033666: Hemaderm (2003), 29 descendants of its own
- K070211: Traumarrest and Bleedarrest Hemostatic Particles and Foam (2007), 28 descendants of its own
- K072900: Excelarrest  Foam (2007), 19 descendants of its own
- K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing (2008), 11 descendants of its own

## Indications for use
ENTaxis™ Nasal Packing is intended for Epistaxis Post operative nasal packing

Source page: https://510kreport.com/device/K984069
Methodology: https://510kreport.com/methodology