FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)
K Number: K861806
·
Decision May 23, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
14
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
- MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)
- K Number
- K861806
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3500
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medcomp Technologies, Inc.
- Date Received
- May 9, 1986
- Decision Date
- May 23, 1986
- Product Code
- KDA
- 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 |
|---|---|---|---|
| KDA | Prosthesis, Ptfe/Carbon-Fiber | FDA class 2 | General, Plastic Surgery |
Other Clearances by Medcomp Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861805 | MEDCARE FORCEPS (THUMB, TISSUE) | May 23, 1986 | Substantially Equivalent |
| K861804 | MEDCARE SUTURE REMOVAL KIT | May 23, 1986 | Substantially Equivalent |
| K861807 | MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP) | May 23, 1986 | Substantially Equivalent |
| K860683 | MEDCARE EMERGENCY SHEARS/PUNCH & FIN TIPS | Mar 13, 1986 | Substantially Equivalent |