ELAN 4 Motor System
FDA 510(k) K152960 · Aesculap, Inc.
510(k) numberK152960
Submission
- Device name
- ELAN 4 Motor System
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- October 7, 2015
- Decision date
- July 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ELAN 4 Motor System cleared by the FDA?
ELAN 4 Motor System (K152960) received a 510(k) decision of Substantially Equivalent on July 22, 2016, 289 days after the submission was received.
What is the product code of K152960?
The FDA product code is HBC – Motor, Drill, Electric, a Class II (moderate risk) device regulated under 21 CFR 882.4360.