ELAN 4 Electro Motor System Tools
FDA 510(k) K172709 · Aesculap, Inc.
510(k) numberK172709
Submission
- Device name
- ELAN 4 Electro Motor System Tools
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- September 8, 2017
- Decision date
- October 17, 2018
- 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 Electro Motor System Tools cleared by the FDA?
ELAN 4 Electro Motor System Tools (K172709) received a 510(k) decision of Substantially Equivalent on October 17, 2018, 404 days after the submission was received.
What is the product code of K172709?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.