DeviceClearance

Product code OOL— Orthopedic

EIDOSMED, MODEL EDG4.0

Classification name
Electronic Depth Gauge
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OOL under 21 CFR 888.3030, via openFDA

Market context for product code OOL

FDA has cleared 1 device under product code OOL, all in 2009, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OOL

Recent clearances under product code OOL

Data sourced from openFDA. This site is unofficial and independent of the FDA.