Yasargil Standard Aneurysm Clip &
FDA 510(k) K833650 · Advanced Biosearch Assn.
510(k) numberK833650
Submission
- Device name
- Yasargil Standard Aneurysm Clip &
- Applicant
- Advanced Biosearch Assn.
Walker, MI, US - Received
- October 19, 1983
- Decision date
- January 18, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code HCH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K091921 | Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft…HCH · Special | Codman & Shurtleff, Inc. | 09/08/2009SE |
| 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 |
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| K854770 | Martin Laminar Osteosynthesis SystemKWP · Traditional | 02/11/1986SE |
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| K855031 | Manual Surgical Instruments & Access.Champy Bone PHWC · Traditional | 01/21/1986SE |
| K853916 | P.M. Hip-Femoral ProsthesisJDI · Traditional | 12/27/1985SE |
| K852839 | Freeman HipJDI · Traditional | 10/29/1985SE |
| K853418 | Safti-BraceletKMK · Traditional | 09/20/1985SE |
| K852517 | CLS Hip ProsthesisJDI · Traditional | 09/18/1985SE |
| K852699 | Freeman Acetabular CupKWA · Traditional | 09/05/1985SE |
Questions and answers
When was Yasargil Standard Aneurysm Clip & cleared by the FDA?
Yasargil Standard Aneurysm Clip & (K833650) received a 510(k) decision of Substantially Equivalent on January 18, 1984, 91 days after the submission was received.
What is the product code of K833650?
The FDA product code is HCH – Clip, Aneurysm, a Class II (moderate risk) device regulated under 21 CFR 882.5200.