FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
K Number: K010666
·
Decision May 7, 2001
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
54
Applicant Total
28
Review Days
62
Basic Information
- Device Name
- XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
- K Number
- K010666
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDTRONIC XOMED, INC.
- Date Received
- March 6, 2001
- Decision Date
- May 7, 2001
- Product Code
- QPB
- 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 |
|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | FDA class 2 | General, Plastic Surgery |
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