Scalpfix Clip System
FDA 510(k) K012219 · Aesculap, Inc.
510(k) numberK012219
Submission
- Device name
- Scalpfix Clip System
- Applicant
- Aesculap, Inc.
Center Valley, PA, US - Received
- July 16, 2001
- Decision date
- July 31, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HBO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253814 | Raney Clips KitHBO · Traditional | Beijing Honghugaoxiang Science and Technology… | 07/21/2026SE |
| K050044 | Medtronic Clip Gun KitHBO · Special | Medtronic Neurosurgery | 02/07/2005SE |
| K033660 | Storz Raney Scalp Clip, Model 1-20-004-05HBO · Traditional | Rudolf Storz GmbH | 01/07/2004SE |
| K944311 | Acra-CutHBO · Traditional | Acra Cut, Inc. | 11/18/1994SE |
| K905433 | Codman Disposable Scalp Clip ApplierHBO · Traditional | Codman & Shurtleff, Inc. | 02/21/1991SE |
| K896723 | Clip Gun with Raney Type Scalp ClipsHBO · Traditional | Omni Medical Designs | 03/23/1990SE |
| K894778 | Codman RF-12 Disposable Scalp Clip ApplierHBO · Traditional | Codman & Shurtleff, Inc. | 12/06/1989SE |
| K890443 | Caspar Scalp Clip, ApplierHBO · Traditional | Aesculap Instruments Corp. | 06/15/1989SE |
| K883963 | Raney and Leroy-Raney Scalp ClipHBO · Traditional | New England Surgical Instrument Corp. | 10/07/1988SE |
| K881265 | Raney ClipsHBO · Traditional | Zimmer, Inc. | 05/31/1988SE |
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| K214041 | Aesculap AICON ContainerKCT · Traditional | 12/30/2022SE |
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| K203739 | ELAN 4 Electro Motor SystemHBE · Traditional | 08/24/2021SE |
| K202391 | Dir 800IZI · Traditional | 01/21/2021SE |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
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Questions and answers
When was Scalpfix Clip System cleared by the FDA?
Scalpfix Clip System (K012219) received a 510(k) decision of Substantially Equivalent on July 31, 2001, 15 days after the submission was received.
What is the product code of K012219?
The FDA product code is HBO – Clip, Scalp, a Class II (moderate risk) device regulated under 21 CFR 882.4150.