Arthrex Vortex Threaded Bone Marrow Recovery Needle
FDA 510(k) K213213 · Arthrex, Inc.
510(k) numberK213213
Submission
- Device name
- Arthrex Vortex Threaded Bone Marrow Recovery Needle
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- September 29, 2021
- Decision date
- November 19, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Arthrex Vortex Threaded Bone Marrow Recovery Needle cleared by the FDA?
Arthrex Vortex Threaded Bone Marrow Recovery Needle (K213213) received a 510(k) decision of Substantially Equivalent on November 19, 2021, 51 days after the submission was received.
What is the product code of K213213?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.