# K160101: SinuBand

- Pathway: 510(k) (Traditional)
- Applicant: Bioinspire Technologies, Incorporated
- Decided: Jul 27, 2016 after 190 days
- Product code: QJL (Splint, Intranasal Septal, Cber Led)
- 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: 4 generations back to K972082 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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 5.
- K070496: Advacoat Sinus Gel and Stent, Carbylan Biosurgery (2007) Summary page 5.
- K082276: Synthemed Device, Synthemed, Inc. (2008) Summary page 5.
- K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ, Polyganics B.V., (2005) Summary page 5.

## Indications for use
SinuBand is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying dressing intended to separate mucosal surfaces and prevent formation of adhesions.

Source page: https://510kreport.com/device/K160101
Methodology: https://510kreport.com/methodology