MKY — System, Skin Closure Class I
FDA product code MKY covers "System, Skin Closure", a Class I medical device regulated under 21 CFR 878.4320. Submissions are reviewed by the General, Plastic Surgery panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MKY
- Device Class
- Class I
- Regulation Number
- 878.4320
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K002315 | wisebands | WISEBANDS SKIN CLOSURE DEVICE | March 15, 2001 |
| K982439 | progressive surgical products | PROXIDERM, MODELS TN 460, TN 90 460, BK 460 | September 8, 1998 |
| K970439 | progressive surgical products | PROXIDERM (D-460,D 90 460,D 180,460, PS 460) | April 16, 1997 |
| K962144 | phoenix biomedical | PHOENIX ETE TISSUE EXTENSION SYSTEM | January 14, 1997 |
| K942425 | progressive surgical products | PROXIDERM (TENTATIVE) | November 4, 1994 |
| K942526 | life medical sciences | SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM | July 19, 1994 |