FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BRIMFIELD CANNULATED BLADE HOLDER
K Number: K852042
·
Decision Jun 11, 1985
Classifications
1
FEI Numbers
430
Registration Numbers
430
Same Product Code
15
Applicant Total
5
Review Days
33
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
- BRIMFIELD CANNULATED BLADE HOLDER
- K Number
- K852042
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Brimfield Scientific Instruments
- Date Received
- May 9, 1985
- Decision Date
- June 11, 1985
- Product Code
- GDZ
- 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 |
|---|---|---|---|
| GDZ | Handle, Scalpel | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDZ), ordered by most recent decision date.
SPECTRA MEDICAL SAFETY SCAPEL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SCALPEL HANDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BEAVER(R) HANDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
THE S. CORDERO STYLUS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KEISEI HANDLES FOR SURGICAL BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Brimfield Scientific Instruments
| K Number | Device Name | ||
|---|---|---|---|
| K843135 | BRIMFIELD CANNULATED MAGNETIC RETRIEVER | Sep 26, 1984 | Substantially Equivalent |
| K843136 | BRIMFIELD CANNULATED GRASPING HOOKS | Sep 25, 1984 | Substantially Equivalent |
| K841731 | BRIMFIELD FIBEROPTIC LIGHT SCOURCE | Jul 16, 1984 | Substantially Equivalent |
| K832147 | CIRCUT 1 | Jul 26, 1983 | Substantially Equivalent |