FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
K Number: K121218
·
Decision Dec 13, 2012
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
57
Applicant Total
3
Review Days
234
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Basic Information
- Device Name
- HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
- K Number
- K121218
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Andrew Technologies, LLC
- Date Received
- April 23, 2012
- Decision Date
- December 13, 2012
- 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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