Leksell Neuro Generator and Accessories
FDA 510(k) K941823 · Elekta Instruments, Inc.
510(k) numberK941823
Submission
- Device name
- Leksell Neuro Generator and Accessories
- Applicant
- Elekta Instruments, Inc.
Atlanta, GA, US - Received
- April 13, 1994
- Decision date
- March 22, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K181864 | Polaris RF Ablation SystemGXD · Traditional | Baylis Medical Company, Inc. | 01/02/2019SE |
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More from Relievant Medsystems
| 510(k) | Device | Decision |
|---|---|---|
| K983678 | Elekta Oncology Systems Precise Treatment TableJAI · Traditional | 01/15/1999SE |
| K955064 | Spetzler Ti 100 Aneurysm ClipHCH · Traditional | 10/17/1996SE |
| K946165 | Cmf-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) SystemHRS · Traditional | 05/23/1995SE |
| K943468 | Leksell SurgiplanHAW · Traditional | 01/20/1995SE |
| K932261 | ES-100 AccessoriesHWE · Traditional | 01/07/1994SE |
| K925360 | ES-100 Power System, ES-100 SeriesGEY · Traditional | 09/07/1993SE |
| K914808 | Leksell Gammaplan (LGP)IWB · Traditional | 01/23/1992SE |
Questions and answers
When was Leksell Neuro Generator and Accessories cleared by the FDA?
Leksell Neuro Generator and Accessories (K941823) received a 510(k) decision of Substantially Equivalent on March 22, 1996, 709 days after the submission was received.
What is the product code of K941823?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.