Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and Appliers
FDA 510(k) K060915 · Kirwan Surgical Products, Inc.
510(k) numberK060915
Submission
- Device name
- Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and Appliers
- Applicant
- Kirwan Surgical Products, Inc.
Marshfield, MA, US - Received
- April 4, 2006
- Decision date
- April 17, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K131500 | Yasargil Aneurysm Clips and Clip AppliersHCH · Traditional | Aesculap, Inc. | 01/24/2014SE |
| K091921 | Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft…HCH · Special | Codman & Shurtleff, Inc. | 09/08/2009SE |
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| K081489 | L-Aneurysm-Clip System & L-Aneurysm Clip Appliers, Yasargil Aneurysm Clips & Yasargil…HCH · Traditional | Peter Lazic GmbH | 09/25/2008SE |
| K043041 | Aesculap T-Bar Aneurysm Clips (Titanium & Phynox)HCH · Special | Aesculap, Inc. | 12/09/2004SE |
| K032198 | Aesculap Yasargil Aneurysm Clip Phynox Booster ClipHCH · Special | Aesculap, Inc. | 08/20/2003SE |
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| K024349 | Aesulap Kopitnik Avm Microclips and ApplierHCH · Traditional | Aesculap, Inc. | 03/24/2003SE |
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Questions and answers
When was Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and Appliers cleared by the FDA?
Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and Appliers (K060915) received a 510(k) decision of Substantially Equivalent on April 17, 2007, 378 days after the submission was received.
What is the product code of K060915?
The FDA product code is HCH – Clip, Aneurysm, a Class II (moderate risk) device regulated under 21 CFR 882.5200.