# K080032: Envoycem, Model 1640

- Pathway: 510(k) (Traditional)
- Applicant: Envoy Medical Corporation
- Decided: Feb 28, 2008 after 52 days
- Product code: NEA (Cement, Ear, Nose And Throat)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 K861369 (1986). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011338: Oto-Cem, Ototech, Inc. (2001)
- K003567: Serenocem, Model BC 010, Corinthian Medical, Ltd. (2001) Summary page 1.
- K042516: Otomimix, Walter Lorenz Surgical, Inc. (2004) Summary page 1.

## Most influential descendants
- K140644: Procem (2014), 0 descendants of its own

## Indications for use
EnvoyCem is intended for use in otologic surgery for the following applications: * Augmentation or coupling of the middle ear ossicles. * Attachment of the middle ear ossicles to middle ear implants. * Mechanical stabilization of middle ear prostheses.

Source page: https://510kreport.com/device/K080032
Methodology: https://510kreport.com/methodology