Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft, Reinforcing, Mini Aneurysm Clip
FDA 510(k) K091921 · Codman & Shurtleff, Inc.
510(k) numberK091921
Submission
- Device name
- Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft, Reinforcing, Mini Aneurysm Clip
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- June 30, 2009
- Decision date
- September 8, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K211183 | Sugita AVM MicroclipsHCH · Traditional | Mizuho America, Inc. | 03/02/2022SE |
| K180757 | D-Clip; D-Clip ApplierHCH · Traditional | Peter Lazic GmbH | 04/12/2019SE |
| K131500 | Yasargil Aneurysm Clips and Clip AppliersHCH · Traditional | Aesculap, Inc. | 01/24/2014SE |
| K081640 | Gimmi Aneurysm Clips and Applying ForcepsHCH · Abbreviated | Gimmi GmbH | 05/06/2009SE |
| K081489 | L-Aneurysm-Clip System & L-Aneurysm Clip Appliers, Yasargil Aneurysm Clips & Yasargil…HCH · Traditional | Peter Lazic GmbH | 09/25/2008SE |
| K060915 | Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and AppliersHCH · Traditional | Kirwan Surgical Products, Inc. | 04/17/2007SE |
| 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 |
| K031468 | Temporary Titanium Aneurysm ClipHCH · Traditional | Cardinalhealth | 06/20/2003SE |
| K024349 | Aesulap Kopitnik Avm Microclips and ApplierHCH · Traditional | Aesculap, Inc. | 03/24/2003SE |
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Questions and answers
When was Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft, Reinforcing, Mini Aneurysm Clip cleared by the FDA?
Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft, Reinforcing, Mini Aneurysm Clip (K091921) received a 510(k) decision of Substantially Equivalent on September 8, 2009, 70 days after the submission was received.
What is the product code of K091921?
The FDA product code is HCH – Clip, Aneurysm, a Class II (moderate risk) device regulated under 21 CFR 882.5200.