FPX — Strip, Adhesive, Closure, Skin Class I
FDA Device Classification
Classification Details
- Product Code
- FPX
- Device Class
- Class I
- Regulation Number
- 880.5240
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K970441 | medi-flex hospital products | K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH | May 9, 1997 |
| K952947 | bitco intl | DELPORE SKIN CLOSURE | July 24, 1995 |
| K952702 | ttl medical | DERMA SEAL | June 28, 1995 |
| K946321 | cornelia damsky | BIOSTRIP STERILE WOUND CLOSURE STRIP | January 12, 1995 |
| K931005 | dukal | DUKAL SKIN CLOSURE STRIP | July 14, 1993 |
| K921775 | polymint industrial co. | SPYROFLEX WOUND CLOSURES | May 19, 1992 |
| K894802 | american white cross | AWC BUTTERFLY WOUND CLOSURES | January 31, 1990 |
| K894205 | tecnol new jersey wound care | TECNOL SILK STRIP | July 25, 1989 |
| K874813 | oxboro medical intl | OMED WOUND CLOSURE STRIPS | January 29, 1988 |
| K840945 | gainor medical | SKIN CLOSURE | October 31, 1984 |
| K842621 | genetic laboratories | SUTURE STRIP | October 25, 1984 |
| K833258 | lee tec | SKIN TECH. SURGI-STRIPS | January 25, 1984 |
| K833083 | howmedica | DERMA STRIP-TM SKIN CLOSURES | December 30, 1983 |
| K831438 | beiersdorf | ELASTOPLAST | November 25, 1983 |
| K831439 | beiersdorf | ELASTOPLAST T.P.N. | September 29, 1983 |
| K821763 | shur medical | SHUR-STRIP APPLICATOR | June 23, 1982 |
| K802385 | american medical disposable | CUSTOM DRESSING TRAY-WET TO DRY/MASS. | November 12, 1980 |
| K802384 | american medical disposable | CENTRAL VENOUS CATHETER DRESSING TRAY | November 12, 1980 |
| K801837 | martin maine exchange | PLASTIC STRIP BANDAGES | October 31, 1980 |
| K801884 | acme united | OP-SITE SKIN CLOSURE SUTURE ADHESIVE | October 10, 1980 |