MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
FDA 510(k) clearance K192099 · decided 2020-04-02
Clearance details
- K-number
- K192099
- Device name
- MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
- Applicant
- Medax Srl Unipersonale
- Decision
- Substantially Equivalent
- Date received
- 2019-08-05
- Decision date
- 2020-04-02
- Days to decision
- 241 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Poggio Rusco, IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.