OOL

Electronic Depth Gauge

Product code
OOL
Device name
Electronic Depth Gauge
Device class
Class 2
21 CFR
21 CFR 888.3030
Medical specialty
Orthopedic
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1

FDA classification definition

For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware. The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other tissue. It may enable the proper sizing of screws and implants in medical procedures.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OOL
Classification and pathway per current FDA publications. Data from openFDA (CC0).