# K973573: Duralastic Anatomical Nasal Implants

- Pathway: 510(k) (Traditional)
- Applicant: Hanson Medical, Inc.
- Decided: Nov 13, 1997 after 55 days
- Product code: FZE (Prosthesis, Nose, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3680
- 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 K952705 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971481: Duralastic Anatomical Nasal Implants, Allied Biomedical Corp. (1997) Summary page 1.

## Most influential descendants
- K090803: Hanson Medical Facial Implants (2010), 0 descendants of its own

## Indications for use
To augment or reconstruct the nasal contour

Source page: https://510kreport.com/device/K973573
Methodology: https://510kreport.com/methodology