OLL · Septal Stapler/Absorbable Staples
General, Plastic Surgery · 21 CFR 878.4750 · Class 2
Overview
| Product Code | OLL |
|---|---|
| Device Name | Septal Stapler/Absorbable Staples |
| Regulation | 21 CFR 878.4750 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K082750 | ENTACT SEPTAL STAPLER, MODEL 610-00100 | Entrigue Surgical, Inc. | Jan 6, 2009 | SESE |
Top Applicants
- Entrigue Surgical, Inc. — 1 clearance
