Clip, Scalp
The Scalp Clip is a temporary hemostatic device applied to the edges of scalp incisions during neurosurgical procedures to control bleeding from the highly vascular scalp, reducing blood loss during craniotomy or other cranial access procedures. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HBO under regulation 21 CFR 882.4150 in the Neurology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HBO
- Device Class
- FDA class 2
- Regulation Number
- 882.4150
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K050044 | MEDTRONIC CLIP GUN KIT | Feb 07, 2005 | Substantially Equivalent | Medtronic Neurosurgery |
| K033660 | STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 | Jan 07, 2004 | Substantially Equivalent | Rudolf Storz GmbH |
| K012219 | SCALPFIX CLIP SYSTEM | Jul 31, 2001 | Substantially Equivalent | Aesculap, Inc. |
| K944311 | ACRA-CUT | Nov 18, 1994 | Substantially Equivalent | Acra Cut, Inc. |
| K905433 | CODMAN DISPOSABLE SCALP CLIP APPLIER | Feb 21, 1991 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K896723 | CLIP GUN WITH RANEY TYPE SCALP CLIPS | Mar 23, 1990 | Substantially Equivalent | Omni Medical Designs |
| K894778 | CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER | Dec 06, 1989 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K890443 | CASPAR SCALP CLIP, APPLIER | Jun 15, 1989 | Substantially Equivalent | Aesculap Instruments Corp. |
| K883963 | RANEY AND LEROY-RANEY SCALP CLIP | Oct 07, 1988 | Substantially Equivalent | New England Surgical Instrument Corp. |
| K881265 | RANEY CLIPS | May 31, 1988 | Substantially Equivalent | Zimmer, Inc. |
FEI Numbers
This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.