Product code MKY
- Device name
- System, Skin Closure
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4320
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K002315 | WISEBANDS SKIN CLOSURE DEVICE | Wisebands , Ltd. | 2001-03-15 |
| K982439 | PROXIDERM, MODELS TN 460, TN 90 460, BK 460 | Progressive Surgical Products, Inc. | 1998-09-08 |
| K970439 | PROXIDERM (D-460,D 90 460,D 180,460, PS 460) | Progressive Surgical Products, Inc. | 1997-04-16 |
| K962144 | PHOENIX ETE TISSUE EXTENSION SYSTEM | Phoenix Biomedical Corp. | 1997-01-14 |
| K942425 | PROXIDERM (TENTATIVE) | Progressive Surgical Products, Inc. | 1994-11-04 |
| K942526 | SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM | Life Medical Sciences, Inc. | 1994-07-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840118613644 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2023-10-15 |
| 00840118611558 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2023-10-15 |
| 00840118611534 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2023-10-15 |
| 00840118611510 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2023-10-15 |
| 00840118611497 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2023-10-15 |
| 00840118611473 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2023-10-15 |
| 00840118611459 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2023-10-15 |
| 00840118611435 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2023-10-15 |
| 00840118605175 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2023-10-15 |
| 08800125000037 | DIALFIX 15 | DFIX | 2023-01-28 |
| 08800125000020 | DIALFIX 11 | DFIX | 2023-01-28 |
| 08800125000044 | DIALFIX 18 | DFIX | 2023-01-28 |
| 08800125000051 | DIALFIX 21 | DFIX | 2023-01-28 |
| 08800125000068 | DIALFIX 24 | DFIX | 2023-01-28 |
| 08800125000075 | DIALFIX PLUS 3 | DFIX | 2023-01-28 |
| 08800125000082 | DIALFIX PLUS 5 | DFIX | 2023-01-28 |
| 00850010207094 | BandGrip® Micro-Anchor® Skin Closure | BANDGRIP INC. | 2021-03-01 |
| 00620974001744 | Dynamic Tissue Systems™ | Southmedic Incorporated | 2020-12-18 |
| 00620974001706 | Dynamic Tissue Systems™ | Southmedic Incorporated | 2020-12-18 |
| 00620974001713 | Dynamic Tissue Systems™ | Southmedic Incorporated | 2020-12-18 |
| 00620974001720 | Dynamic Tissue Systems™ | Southmedic Incorporated | 2020-12-18 |
| 00620974001775 | Dynamic Tissue Systems™ | Southmedic Incorporated | 2020-12-18 |
| 00620974001768 | Dynamic Tissue Systems™ | Southmedic Incorporated | 2020-12-18 |
| 00620974001751 | Dynamic Tissue Systems™ | Southmedic Incorporated | 2020-12-18 |
| 00620974001737 | Dynamic Tissue Systems™ | Southmedic Incorporated | 2020-12-18 |
| 00850010207070 | BandGrip® Micro-Anchor® Skin Closure | BANDGRIP INC. | 2020-03-24 |
| 00850010207087 | BandGrip® Micro-Anchor® Skin Closure | BANDGRIP INC. | 2020-03-24 |
| 00850010207100 | BandGrip® Micro-Anchor® Skin Closure | BANDGRIP INC. | 2020-03-24 |
| 00850010207117 | BandGrip® Micro-Anchor® Skin Closure | BANDGRIP INC. | 2020-03-24 |
| 00850010207124 | BandGrip® Micro-Anchor® Skin Closure | BANDGRIP INC. | 2020-03-24 |