FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KLEIN LAMPREY-CANNULA(TM)
K Number: K901718
·
Decision May 24, 1990
Classifications
1
FEI Numbers
375
Registration Numbers
375
Same Product Code
35
Applicant Total
5
Review Days
41
Basic Information
- Device Name
- KLEIN LAMPREY-CANNULA(TM)
- K Number
- K901718
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- JEFF KLEIN SURGICAL, INC.
- Date Received
- April 13, 1990
- Decision Date
- May 24, 1990
- Product Code
- GEA
- 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 |
|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEA), ordered by most recent decision date.
MRI SAFE INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GENICON TROCAR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CONMED TROGARD ELECTRONIC TROCAR SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ORIGIN SECONDARY CANNULA AND TROCAR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery