FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013
K Number: K031173
·
Decision Jul 23, 2003
Classifications
1
FEI Numbers
236
Registration Numbers
236
Same Product Code
27
Applicant Total
3
Review Days
100
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
- NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013
- K Number
- K031173
- 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
- Needle Tech Products, Inc.
- Date Received
- April 14, 2003
- Decision Date
- July 23, 2003
- Product Code
- GDF
- 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 |
|---|---|---|---|
| GDF | Guide, Needle, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDF), ordered by most recent decision date.
GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL INSTRUMENT GUIDE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BREAST LESION LOCALIZATION NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BREAST LESION LOCALIZATION NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BAUER TEMNO COAXIAL NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LOCALIZATION WIRE OR MARKER - SURGICAL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery