510(k) K091992
K091992 is an FDA 510(k) premarket notification submitted by Eidosmed, LLC for the device "EIDOSMED, MODEL EDG4.0". The FDA issued a decision of Substantially Equivalent on December 9, 2009. The device falls under product code OOL (Electronic Depth Gauge), a Class II device regulated under 21 CFR 888.3030.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2009
- Date Received
- July 2, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electronic Depth Gauge
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
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.