MKY · System, Skin Closure
General, Plastic Surgery · 21 CFR 878.4320 · Class 1
Overview
| Product Code | MKY |
|---|---|
| Device Name | System, Skin Closure |
| Regulation | 21 CFR 878.4320 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K002315 | WISEBANDS SKIN CLOSURE DEVICE | Wisebands , Ltd. | Mar 15, 2001 | SESE |
| K982439 | PROXIDERM, MODELS TN 460, TN 90 460, BK 460 | Progressive Surgical Products, Inc. | Sep 8, 1998 | SESE |
| K970439 | PROXIDERM (D-460,D 90 460,D 180,460, PS 460) | Progressive Surgical Products, Inc. | Apr 16, 1997 | SESE |
| K962144 | PHOENIX ETE TISSUE EXTENSION SYSTEM | Phoenix Biomedical Corp. | Jan 14, 1997 | SESE |
| K942425 | PROXIDERM (TENTATIVE) | Progressive Surgical Products, Inc. | Nov 4, 1994 | SESE |
| K942526 | SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM | Life Medical Sciences, Inc. | Jul 19, 1994 | SESE |
Top Applicants
- Progressive Surgical Products, Inc. — 3 clearances
- Life Medical Sciences, Inc. — 1 clearance
- Phoenix Biomedical Corp. — 1 clearance
- Wisebands , Ltd. — 1 clearance
