FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL BLADE HANDLES
K Number: K761035
·
Decision Dec 21, 1976
Classifications
1
FEI Numbers
430
Registration Numbers
430
Same Product Code
15
Applicant Total
47
Review Days
36
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
- SURGICAL BLADE HANDLES
- K Number
- K761035
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Parke-Davis Co.
- Date Received
- November 15, 1976
- Decision Date
- December 21, 1976
- 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 Parke-Davis Co.
| K Number | Device Name | ||
|---|---|---|---|
| K861725 | INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT | Dec 4, 1986 | Substantially Equivalent |
| K862119 | DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR | Aug 29, 1986 | Substantially Equivalent |
| K855120 | ATI DISPOSABLE BIOLOGICAL TEST PACK | Jun 18, 1986 | Substantially Equivalent |
| K860570 | ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE | Mar 31, 1986 | Substantially Equivalent |
| K860290 | VIAPIC CENTRAL LINE CATHETER | Mar 18, 1986 | Substantially Equivalent |
| K852192 | DISPOSABLE STEAM BIOLOGICAL TEST PACK | Nov 1, 1985 | Substantially Equivalent |
| K841967 | DESERET THERMODILUTION CARDIAC OUTPUT | Aug 19, 1985 | Substantially Equivalent |
| K851327 | DESERET ARTERIAL CATHETER | Jun 14, 1985 | Substantially Equivalent |
| K852078 | SPECTRUM(TENTATIVE) | Jun 7, 1985 | Substantially Equivalent |
| K844840 | DESERET INTRODUCER SET | May 16, 1985 | Substantially Equivalent |