FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MultiGen 2 RF Generator System
K Number: K170242
·
Decision May 25, 2017
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
36
Applicant Total
81
Review Days
119
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MultiGen 2 RF Generator System
- K Number
- K170242
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Corporation
- Date Received
- January 26, 2017
- Decision Date
- May 25, 2017
- Product Code
- GXD
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXD | Generator, Lesion, Radiofrequency | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXD), ordered by most recent decision date.
GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
FDA 510(k)
FDA Class 2
·Neurology
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
FDA 510(k)
FDA Class 2
·Neurology
Racz Neurostat RF Generator
FDA 510(k)
FDA Class 2
·Neurology
OneRF Ablation System
FDA 510(k)
FDA Class 2
·Neurology
APEX 6
FDA 510(k)
FDA Class 2
·Neurology
Abbott Medical Grounding Pad, model RF-DGP-IS
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Stryker Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control | Aug 18, 2023 | Substantially Equivalent |
| K223770 | Sonopet 1Q 3 7cm 1Q Large | Feb 16, 2023 | Substantially Equivalent |
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System | Feb 16, 2023 | Substantially Equivalent |
| K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate | Oct 19, 2022 | Substantially Equivalent |
| K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device | Sep 16, 2022 | Substantially Equivalent |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | Jul 12, 2022 | Substantially Equivalent |
| K213824 | Sonopet iQ Ultrasonic Aspirator System | Feb 3, 2022 | Substantially Equivalent |
| K212055 | Connected OR Hub with Device and Voice Control | Dec 16, 2021 | Substantially Equivalent |
| K210377 | Stryker iBur hubs and cutting accessories | Jun 30, 2021 | Substantially Equivalent |
| K202964 | iBed Wireless with iBed Mobile | Jun 18, 2021 | Substantially Equivalent |