Surgery and Accessories
FDA 510(k) K021236 · Camtronics, Ltd.
510(k) numberK021236
Submission
- Device name
- Surgery and Accessories
- Applicant
- Camtronics, Ltd.
Hartland, WI, US - Received
- April 18, 2002
- Decision date
- July 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262060 | 3D-RD-SLLZ · Traditional | Radiopharmaceutical Imaging & Dosimetry, LLC | 09/04/2026SE |
| K261500 | KBA3D (v2.4.0)LLZ · Traditional | S.M.A.I.O | 08/17/2026SE |
| K262449 | AdvaViewLLZ · Special | Advahealth Solutions, LLC | 08/14/2026SE |
| K261916 | NeuroQuant PETLLZ · Traditional | Cortechs Labs, Inc. | 08/12/2026SE |
| K260936 | RadioViewAILLZ · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 07/31/2026SE |
| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
| K260500 | ResolutionMDLLZ · Traditional | ResolutionMD, Inc. | 07/21/2026SE |
| K262120 | Avara ViewerLLZ · Traditional | Avara Software | 07/10/2026SE |
More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K013032 | Physiolog, Series 95000DQK · Traditional | 06/04/2002SE |
| K992666 | Video Plus System, Series 95000LLZ · Traditional | 10/13/1999SE |
| K992259 | Echocardiography System Series 95000LLZ · Traditional | 09/08/1999SE |
| K990066 | CCD Camera, Model 9000LMA · Traditional | 03/17/1999SE |
| K955519 | Analytical Review StationIZI · Traditional | 05/09/1996SE |
| K954159 | Digital Imaging SystemLLZ · Traditional | 03/19/1996SE |
| K955232 | NT Series Digital Image ManagerLMB · Traditional | 12/11/1995SE |
| K953080 | Digital Imaging System InterfaceLMD · Traditional | 09/28/1995SE |
| K945654 | Nicom Digital Image ManagerLMB · Traditional | 02/17/1995SE |
| K941979 | Video Plus with Analytical WorkstationIZI · Traditional | 08/17/1994SE |
Questions and answers
When was Surgery and Accessories cleared by the FDA?
Surgery and Accessories (K021236) received a 510(k) decision of Substantially Equivalent on July 17, 2002, 90 days after the submission was received.
What is the product code of K021236?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.