FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUVANCE* FACIAL REJUVENATION SYSTEM
K Number: K052953
·
Decision Mar 6, 2006
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
1
Applicant Total
172
Review Days
137
Basic Information
- Device Name
- NUVANCE* FACIAL REJUVENATION SYSTEM
- K Number
- K052953
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ETHICON, INC.
- Date Received
- October 20, 2005
- Decision Date
- March 6, 2006
- Product Code
- MXW
- 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 |
|---|---|---|---|
| MXW | Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride) | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MXW), ordered by most recent decision date.
View allOther Clearances by ETHICON, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K161726 | E-Pack Procedure Kit | Jul 12, 2016 | Substantially Equivalent |
| K152490 | DERMABOND PRINEO Skin Closure System | Nov 25, 2015 | Substantially Equivalent |
| K151200 | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | Aug 13, 2015 | Substantially Equivalent |
| K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device | Jul 2, 2015 | Substantially Equivalent |
| K141560 | ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE | Oct 23, 2014 | Substantially Equivalent |
| K141776 | STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES | Oct 15, 2014 | Unknown |
| K133198 | ULTRAPRO COMFORT PLUG | May 30, 2014 | Substantially Equivalent |
| K133864 | DERMABOND PRINEO SKIN CLOSURE SYSTEM | Mar 10, 2014 | Substantially Equivalent |
| K132580 | COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE | Feb 28, 2014 | Substantially Equivalent |
| K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | Dec 6, 2013 | Substantially Equivalent |