NEH · Anchor, Fascial
General, Plastic Surgery · 21 CFR 878.4300 · Class 2
Overview
| Product Code | NEH |
|---|---|
| Device Name | Anchor, Fascial |
| Regulation | 21 CFR 878.4300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
An implantable clip is a clip-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 |
|---|---|---|---|---|
| K010277 | AMS FASCIAL-ANCHORING SYSTEM | American Medical Systems, Inc. | Mar 26, 2001 | SESE |
Top Applicants
- American Medical Systems, Inc. — 1 clearance
