# K183015: PuraSinus

- Pathway: 510(k) (Traditional)
- Applicant: 3-D Matrix, Inc.
- Decided: Apr 12, 2019 after 163 days
- Product code: NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Dec 2, 2019 · Class II · Z-0744-2022: The boxes used by the shipper were not validated for use during transport.

Source page: https://510kreport.com/device/K183015
Methodology: https://510kreport.com/methodology