# K091992: Eidosmed, Model EDG4.0

- Pathway: 510(k) (Traditional)
- Applicant: Eidosmed, LLC
- Decided: Dec 9, 2009 after 160 days
- Product code: OOL (Electronic Depth Gauge)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K873191 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873191: Acromed Interbody Depth Gauges, Buckman Co., Inc. (1987) Summary page 1.

## Indications for use
The Eidosmed EDG is an electronic depth gauge, a measuring device intended for various medical purposes including, but not limited to, measuring the depth of a passageway in a bone br other tissue. The EDG enables the proper sizing of screws and implants in medical procedures.

Source page: https://510kreport.com/device/K091992
Methodology: https://510kreport.com/methodology