FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Marrow Cellution Bone Marrow Aspiration Needle
K Number: K150563
·
Decision May 22, 2015
Classifications
1
FEI Numbers
198
Registration Numbers
198
Same Product Code
353
Applicant Total
1
Review Days
77
Basic Information
- Device Name
- Marrow Cellution Bone Marrow Aspiration Needle
- K Number
- K150563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RANFAC CORP
- Date Received
- March 6, 2015
- Decision Date
- May 22, 2015
- Product Code
- KNW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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