FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MENSINK-GOOSEN CATHETER
K Number: K844889
·
Decision Mar 18, 1985
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
2
Applicant Total
4
Review Days
91
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
- MENSINK-GOOSEN CATHETER
- K Number
- K844889
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Goosen Enterprises, Inc.
- Date Received
- December 17, 1984
- Decision Date
- March 18, 1985
- Product Code
- GBP
- 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 |
|---|---|---|---|
| GBP | Catheter, Multiple Lumen | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBP), ordered by most recent decision date.
MULTILUMEN INTRAVENOUS INFUSION CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CATHETER, MULTIPLE LUMEN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery