510(k) K152960
K152960 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "ELAN 4 Motor System". The FDA issued a decision of Substantially Equivalent on July 22, 2016. The device falls under product code HBC (Motor, Drill, Electric), a Class II device regulated under 21 CFR 882.4360. Aesculap, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2016
- Date Received
- October 7, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Drill, Electric
- Device Class
- Class II
- Regulation Number
- 882.4360
- Review Panel
- NE
- Submission Type