FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BAUER TEMNO COAXIAL NEEDLE
K Number: K935538
·
Decision Feb 22, 1994
Classifications
1
FEI Numbers
236
Registration Numbers
236
Same Product Code
27
Applicant Total
3
Review Days
98
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
- BAUER TEMNO COAXIAL NEEDLE
- K Number
- K935538
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bauer Medical, Inc.
- Date Received
- November 16, 1993
- Decision Date
- February 22, 1994
- 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.
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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
LOCALIZATION WIRE OR MARKER - SURGICAL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery