MCH · Clip, Hemostatic
General, Plastic Surgery · 21 CFR 878.4300 · Class 2
Overview
| Product Code | MCH |
|---|---|
| Device Name | Clip, Hemostatic |
| 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K040148 | RESOLUTION HEMOSTASIS CLIPPING DEVICE | Boston Scientific Corp | Apr 22, 2004 | SESE |
| K972745 | TITANIUM HEMOSTATIC CLIP | Eisner USA, Inc. | Oct 21, 1997 | SESE |
| K896998 | ATRAUCLIP (TANTALUM HEMOSTATIC CLIP) | S.P.K. Technology, Inc. | Jun 1, 1990 | SESE |
Top Applicants
- S.P.K. Technology, Inc. — 1 clearance
- Eisner USA, Inc. — 1 clearance
- Boston Scientific Corp — 1 clearance
