FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BLADE, HANDLE, SCALPEL FORCEPS, SURGERY
K Number: K810572
·
Decision Mar 20, 1981
Classifications
1
FEI Numbers
300
Registration Numbers
300
Same Product Code
47
Applicant Total
3
Review Days
17
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
- BLADE, HANDLE, SCALPEL FORCEPS, SURGERY
- K Number
- K810572
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Technical Resources, Inc.
- Date Received
- March 3, 1981
- Decision Date
- March 20, 1981
- Product Code
- GES
- 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 |
|---|---|---|---|
| GES | Blade, Scalpel | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GES), ordered by most recent decision date.
PERSONNA PLUS SAFETY SCALPEL SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EASY-ON
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LOS ALAMOS RETRACTABLE KNIFE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SCALPEL BLADE REMOVER (BLADEGARD)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PRECISION GLIDE - ENHANCED SURGICAL BLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STERILE CARBON STEEL SURGICAL BLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery