FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MARROWMINER
K Number: K071732
·
Decision Sep 24, 2007
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
47
Applicant Total
1
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MARROWMINER
- K Number
- K071732
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stemcor Systems, Inc.
- Date Received
- June 26, 2007
- Decision Date
- September 24, 2007
- Product Code
- GDM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GDM | Needle, Aspiration And Injection, Reusable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDM), ordered by most recent decision date.
BIOACCESS MARROW HARVEST SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ILIAC CREST BONE MARROW ASPIRATION NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BIOACCESS MARROW HARVEST SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDO-NEEDLE INSTRUMENT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BONE MARROW BIOPSY SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery