FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HAWKINS BREAST LOCALIZATION NEEDLE
K Number: K870523
·
Decision Mar 9, 1987
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
47
Applicant Total
5
Review Days
31
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
- HAWKINS BREAST LOCALIZATION NEEDLE
- K Number
- K870523
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- N-S Medical Products
- Date Received
- February 6, 1987
- Decision Date
- March 9, 1987
- 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.
MARROWMINER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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
Other Clearances by N-S Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K880287 | TRU-TRAC COILED GUIDEWIRE | Sep 12, 1988 | Substantially Equivalent |
| K880288 | TRU-TRAC TORQUE GUIDEWIRE | Sep 12, 1988 | Substantially Equivalent |
| K881956 | NATIONAL-STANDARD NEEDLE HOLDER | May 20, 1988 | Substantially Equivalent |
| K881957 | HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT | May 20, 1988 | Substantially Equivalent |