# K982870: Epifilm Otologic Lamina

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Nov 3, 1998 after 81 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K150594: Biodesign Otologic Repair Graft (2015), 2 descendants of its own
- K161000: Biodesign Otologic Repair Graft (2016), 1 descendant of its own
- K232646: Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) (2024), 0 descendants of its own

## Indications for use
The Xomed EpiFilm™ Otologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures.

Source page: https://510kreport.com/device/K982870
Methodology: https://510kreport.com/methodology