MKY
6 FDA 510(k) clearances · Product code
168 daysmedian time to decision
227 days90th percentile
6clearances measured
FDA profile
- Official device name
- System, Skin Closure
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4320
- Medical specialty
- General, Plastic Surgery
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| WISEBANDS SKIN CLOSURE DEVICE (K002315) | Wisebands , Ltd. | 2001-03-15 |
| PROXIDERM, MODELS TN 460, TN 90 460, BK 460 (K982439) | Progressive Surgical Products, Inc. | 1998-09-08 |
| PROXIDERM (D-460,D 90 460,D 180,460, PS 460) (K970439) | Progressive Surgical Products, Inc. | 1997-04-16 |
| PHOENIX ETE TISSUE EXTENSION SYSTEM (K962144) | Phoenix Biomedical Corp. | 1997-01-14 |
| PROXIDERM (TENTATIVE) (K942425) | Progressive Surgical Products, Inc. | 1994-11-04 |
| SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM (K942526) | Life Medical Sciences, Inc. | 1994-07-19 |
Track MKY automatically
Every clearance here is in the API, with alerts when new ones post.