Breast Lesion Localization Needle
FDA 510(k) K881697 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK881697
Submission
- Device name
- Breast Lesion Localization Needle
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- April 19, 1988
- Decision date
- September 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Breast Lesion Localization Needle cleared by the FDA?
Breast Lesion Localization Needle (K881697) received a 510(k) decision of Substantially Equivalent on September 14, 1988, 148 days after the submission was received.
What is the product code of K881697?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.