MultiGen 2 RF Generator System
FDA 510(k) K170242 · Stryker Corporation
510(k) numberK170242
Submission
- Device name
- MultiGen 2 RF Generator System
- Applicant
- Stryker Corporation
Kalamazoo, MI, US - Received
- January 26, 2017
- Decision date
- May 25, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K181864 | Polaris RF Ablation SystemGXD · Traditional | Baylis Medical Company, Inc. | 01/02/2019SE |
| K171143 | Relievant Medsystems RF GeneratorGXD · Traditional | Relievant Medsystems | 08/18/2017SE |
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Questions and answers
When was MultiGen 2 RF Generator System cleared by the FDA?
MultiGen 2 RF Generator System (K170242) received a 510(k) decision of Substantially Equivalent on May 25, 2017, 119 days after the submission was received.
What is the product code of K170242?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.