# K192661: LATERA Absorbable Nasal Implant System

- Pathway: 510(k) (Special)
- Applicant: Entellus Medical, Inc. (Aka Stryker Ent)
- Decided: Nov 10, 2019 after 46 days
- Product code: NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable)
- 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: 2 generations back to K152958 (2015). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161191: Latera Absorbable Nasal Implant, Spirox, Inc. (2016) Summary page 4.

## Indications for use
The LATERA Absorbable Nasal Implant System is indicated for supporting upper and lower lateral nasal cartilage.

Source page: https://510kreport.com/device/K192661
Methodology: https://510kreport.com/methodology