FDA product code OOL: Electronic Depth Gauge
OOL is the FDA product code for electronic depth gauge. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under OOL. The average 510(k) review took 160 days (median 160).
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.
Classification
| Field | Value |
|---|---|
| Device name | Electronic Depth Gauge |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OOL clearance
Top OOL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eidosmed, LLC | 1 | 2009-12-09 |
Most recent OOL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091992 | Eidosmed, LLC | EIDOSMED, MODEL EDG4.0 | 2009-12-09 | 160 |
Recalls for OOL devices
openFDA lists no recalls for product code OOL.
Frequently asked questions
What is FDA product code OOL?
OOL is the FDA product code for electronic depth gauge. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is OOL?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code OOL?
Across 1 cleared submissions the average was 160 days from receipt to decision (median 160).
Which companies have the most OOL clearances?
Eidosmed, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OOL
- Run a recall and safety report across every OOL manufacturer
- Watch product code OOL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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