PYE · Staple Removal Kit
General, Plastic Surgery · 21 CFR 878.4760 · Class 1
Overview
| Product Code | PYE |
|---|---|
| Device Name | Staple Removal Kit |
| Regulation | 21 CFR 878.4760 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A removable skin staple is a staple-like device intended to connect external 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K844110 | XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001 | Pelco, Inc. | Nov 19, 1984 | SESE |
Top Applicants
- Pelco, Inc. — 1 clearance
