# K043035: Sepragel Ent Bioresorbable Packing/Stent

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corporation
- Decided: Jul 11, 2005 after 250 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K821150 (1982). 13 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012532: Sepragel Sinus, Genzyme Corp. (2001) Summary page 1.
- K993362: Hylasine, Biomatrix, Inc. (2000) Summary page 1.
- K001148: Merogel Otologic Pack, Xomed, Inc. (2000) Summary page 1.
- K002972: Merogel Control Gel Ent Surgical Dressing, Medtronic Xomed (2000) Summary page 1.

## Most influential descendants
- K113585: Nasal/Epistaxis Pack (2012), 7 descendants of its own
- K141704: Novashield Injectable Nasal Packing and Stent (2014), 2 descendants of its own
- K122494: Posisep and Posisep X Hemostat Dressing/Intranasal Splint (2013), 2 descendants of its own
- K172179: Chitogel Endoscopic Sinus Surgery Kit (2017), 1 descendant of its own
- K070886: Merogel Injectable Bioresorbable Stent (2007), 1 descendant of its own

## Indications for use
Sepragel ENT packing/stent is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. The device is indicated for use in the middle ear following canalplasty, myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate during the post operative period.

Source page: https://510kreport.com/device/K043035
Methodology: https://510kreport.com/methodology