Medtronic Clip Gun Kit
FDA 510(k) K050044 · Medtronic Neurosurgery
510(k) numberK050044
Submission
- Device name
- Medtronic Clip Gun Kit
- Applicant
- Medtronic Neurosurgery
Goleta, CA, US - Received
- January 10, 2005
- Decision date
- February 7, 2005
- 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 |
| K033660 | Storz Raney Scalp Clip, Model 1-20-004-05HBO · Traditional | Rudolf Storz GmbH | 01/07/2004SE |
| K012219 | Scalpfix Clip SystemHBO · Special | Aesculap, Inc. | 07/31/2001SE |
| 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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| K123524 | Medtronic Strata NSC Lumboperitoneal Valve and Shunt SystemJXG · Traditional | 02/13/2013SE |
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| K091312 | PS Medical Strata NSC Lumboperitoneal Valve and Shunt SystemJXG · Traditional | 09/02/2009SE |
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Questions and answers
When was Medtronic Clip Gun Kit cleared by the FDA?
Medtronic Clip Gun Kit (K050044) received a 510(k) decision of Substantially Equivalent on February 7, 2005, 28 days after the submission was received.
What is the product code of K050044?
The FDA product code is HBO – Clip, Scalp, a Class II (moderate risk) device regulated under 21 CFR 882.4150.