BD Eclipse Hypodermic Needle
FDA 510(k) K161170 · Becton, Dickinson and Company
510(k) numberK161170
Submission
- Device name
- BD Eclipse Hypodermic Needle
- Applicant
- Becton, Dickinson and Company
Franklin Lakes, NJ, US - Received
- April 26, 2016
- Decision date
- May 27, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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Questions and answers
When was BD Eclipse Hypodermic Needle cleared by the FDA?
BD Eclipse Hypodermic Needle (K161170) received a 510(k) decision of Substantially Equivalent on May 27, 2016, 31 days after the submission was received.
What is the product code of K161170?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.