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