# K012532: Sepragel Sinus

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Oct 30, 2001 after 85 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: 1 generation back to K972082 (1997). 3 ancestors in all.
47 later devices descend from it; 6 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982731: Merogel Nasal Dressing and Sinus Stent, Xomed, Inc. (1999) Summary page 1.
- K972082: Custom Nasal Splint, Boston Medical Products, Inc. (1997) Summary page 1.
- K002131: Lactosorb Ethmoid Stent, Walter Lorenz Surgical, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ (2005), 17 descendants of its own
- K080818: Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing (2008), 11 descendants of its own

## Indications for use
HylaSine is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying gel stent to separate and prevent adhesions between mucosal surfaces in the nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to prevent lateralization of the middle turbinate during the postoperative period.

Source page: https://510kreport.com/device/K012532
Methodology: https://510kreport.com/methodology