# K813224: Ceravital Ceramic Ear Canal Wall Prosth

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Apr 21, 1982 after 163 days
- Product code: ESF (Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent)
- Device class: 2
- Regulation: 21 CFR 878.3500
- Recalls of this device: none
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

Source page: https://510kreport.com/device/K813224
Methodology: https://510kreport.com/methodology