HBO · Clip, Scalp
Neurology · 21 CFR 882.4150 · Class 2
Overview
| Product Code | HBO |
|---|---|
| Device Name | Clip, Scalp |
| Regulation | 21 CFR 882.4150 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050044 | MEDTRONIC CLIP GUN KIT | Medtronic Neurosurgery | Feb 7, 2005 | SESE |
| K033660 | STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 | Rudolf Storz GmbH | Jan 7, 2004 | SESE |
| K012219 | SCALPFIX CLIP SYSTEM | Aesculap, Inc. | Jul 31, 2001 | SESE |
| K944311 | ACRA-CUT | Acra Cut, Inc. | Nov 18, 1994 | SESE |
| K905433 | CODMAN DISPOSABLE SCALP CLIP APPLIER | Codman & Shurtleff, Inc. | Feb 21, 1991 | SESE |
| K896723 | CLIP GUN WITH RANEY TYPE SCALP CLIPS | Omni Medical Designs | Mar 23, 1990 | SESE |
| K894778 | CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER | Codman & Shurtleff, Inc. | Dec 6, 1989 | SESE |
| K890443 | CASPAR SCALP CLIP, APPLIER | Aesculap Instruments Corp. | Jun 15, 1989 | SESE |
| K883963 | RANEY AND LEROY-RANEY SCALP CLIP | New England Surgical Instrument Corp. | Oct 7, 1988 | SESE |
| K881265 | RANEY CLIPS | Zimmer, Inc. | May 31, 1988 | SESE |
Top Applicants
- Codman & Shurtleff, Inc. — 2 clearances
- Zimmer, Inc. — 1 clearance
- Rudolf Storz GmbH — 1 clearance
- Omni Medical Designs — 1 clearance
- New England Surgical Instrument Corp. — 1 clearance
