FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MACROPORE PURICEL LIPOPLASTY SYSTEM
K Number: K042261
·
Decision Sep 20, 2004
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
57
Applicant Total
17
Review Days
28
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Basic Information
- Device Name
- MACROPORE PURICEL LIPOPLASTY SYSTEM
- K Number
- K042261
- 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
- Macropore Biosurgery, Inc.
- Date Received
- August 23, 2004
- Decision Date
- September 20, 2004
- 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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Other Clearances by Macropore Biosurgery, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041105 | MACROPORE HYDROSORB SPINE SYSTEM | Jul 28, 2004 | Substantially Equivalent |
| K031955 | MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET | Sep 22, 2003 | Substantially Equivalent |
| K031785 | MACROPORE CARDIO-WRAP (TS) | Sep 4, 2003 | Substantially Equivalent |
| K024169 | MACROPORE OS RECONSTRUCTION | Jul 1, 2003 | Substantially Equivalent |
| K023643 | MACROPORE SURGICAL BARRIER FILM | Feb 21, 2003 | Substantially Equivalent |
| K021164 | MACROPORE OS TRAUMA | Jul 1, 2002 | Substantially Equivalent |
| K012025 | MACROPORE SURGIWRAP (TS) | Dec 3, 2001 | Substantially Equivalent |
| K012769 | MACROPORE ENT RECONSTRUCTION FILM | Oct 25, 2001 | Substantially Equivalent |
| K012413 | MACROPORE FX, PS, NS, LP | Sep 18, 2001 | Substantially Equivalent |
| K011715 | MACROPORE IB RESORBABLE PLUG | Aug 27, 2001 | Unknown |