FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CURAD SCAR THERAPY
K Number: K024057
·
Decision Jun 18, 2003
Classifications
1
FEI Numbers
190
Registration Numbers
190
Same Product Code
80
Applicant Total
45
Review Days
191
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
- CURAD SCAR THERAPY
- K Number
- K024057
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4025
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beiersdorf, Inc.
- Date Received
- December 9, 2002
- Decision Date
- June 18, 2003
- Product Code
- MDA
- 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 |
|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MDA), ordered by most recent decision date.
NEODYNE DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CORELEADER SCAR-DIMMER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BEAU RX SCAR CARE GEL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KELO-COTE SPRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NEWGEL AND NEWGEL PLUS E
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HANSON SCAR ADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Beiersdorf, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090921 | ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 | Dec 18, 2009 | Substantially Equivalent |
| K952526 | CUTINOVA CAVITY | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K943363 | CUTIPLAST STERIL | Mar 15, 1995 | Substantially Equivalent |
| K944581 | CUTINOVA THIN WOUND DRESSING | Dec 2, 1994 | Substantially Equivalent for Some Indications |
| K935630 | NORTA | Oct 7, 1994 | Substantially Equivalent |
| K940378 | COVERLET ADHESIVE DRESSING | Jul 29, 1994 | Substantially Equivalent for Some Indications |
| K925630 | ELASTOPLAST HEAT PLASTER | Feb 25, 1994 | Substantially Equivalent |
| K926399 | CUTIFILM(R) FILM | Nov 15, 1993 | Substantially Equivalent |
| K923404 | LUEKOFLEX SURGICAL TAPE | Sep 9, 1992 | Substantially Equivalent |
| K921759 | ACRYLASTIC | Aug 10, 1992 | Substantially Equivalent |