FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAMLOC SYRINGE BIOPSY KIT
K Number: K801304
·
Decision Jun 17, 1980
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
6
Applicant Total
4
Review Days
9
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
- CAMLOC SYRINGE BIOPSY KIT
- K Number
- K801304
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Johannah Medical Services, Inc.
- Date Received
- June 8, 1980
- Decision Date
- June 17, 1980
- Product Code
- GEE
- 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 |
|---|---|---|---|
| GEE | Brush, Biopsy, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEE), ordered by most recent decision date.
STERILE SOFT TISSUE BIOPSY NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BIOPSY PUNCH, VARIOUS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DEFLECTING CYTOLOGY BRUSH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STERILE CYTOLOGY BRUSHES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WHISK-R
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TROTEX II SCREW NEEDLE BIOPSY INSTR. SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery