BNX Fine Needle Aspiration System
FDA 510(k) K142198 · Covidien, LLC
510(k) numberK142198
Submission
- Device name
- BNX Fine Needle Aspiration System
- Applicant
- Covidien, LLC
Auburndale, MA, US - Received
- August 11, 2014
- Decision date
- October 8, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was BNX Fine Needle Aspiration System cleared by the FDA?
BNX Fine Needle Aspiration System (K142198) received a 510(k) decision of Substantially Equivalent on October 8, 2014, 58 days after the submission was received.
What is the product code of K142198?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.