FZQ · Clip, Removable (Skin)
General, Plastic Surgery · 21 CFR 878.4320 · Class 1
Overview
| Product Code | FZQ |
|---|---|
| Device Name | Clip, Removable (Skin) |
| 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 |
|---|---|---|---|---|
| K884783 | RANEY CLIP | Alto Development Corp. | Nov 30, 1988 | SESE |
| K873744 | LEUKOCLIP(R) | Beiersdorf, Inc. | Sep 30, 1987 | SESE |
| K830768 | DISPOSABLE SKIN STAPLER | Surgeons Choice, Inc. | Apr 12, 1983 | SESE |
| K830704 | ONE TIME DISPOSABLE SKIN STAPLER | Acme United Corp. | Apr 12, 1983 | SESE |
| K822963 | SURGICAL PRODUCTS, SKIN STAPLE REMOVER | Temp-Stik Corp. | Nov 8, 1982 | SESE |
| K822145 | COMPLETE | Richard-Allan Medical Ind., Inc. | Oct 22, 1982 | SESE |
Top Applicants
- Acme United Corp. — 1 clearance
- Alto Development Corp. — 1 clearance
- Beiersdorf, Inc. — 1 clearance
- Richard-Allan Medical Ind., Inc. — 1 clearance
- Surgeons Choice, Inc. — 1 clearance
