FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUWAVE Microwave Ablation System and Accessories
K Number: K200081
·
Decision Nov 13, 2020
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
67
Applicant Total
15
Review Days
303
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Basic Information
- Device Name
- NEUWAVE Microwave Ablation System and Accessories
- K Number
- K200081
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuwave Medical, Inc.
- Date Received
- January 15, 2020
- Decision Date
- November 13, 2020
- Product Code
- NEY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| NEY | System, Ablation, Microwave And Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NEY), ordered by most recent decision date.
Microwave Ablation Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
swiftPro System (SWF-SPS); Swift System (SWF-SYS)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Microwave Ablation Generator (KY-2000A, KY-2100A)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Microwave Ablation Antennas
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Neuwave Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232227 | ABLATE-IQ | Apr 4, 2024 | Substantially Equivalent |
| K231738 | NEUWAVE Microwave Ablation System and Accessories | Nov 16, 2023 | Substantially Equivalent |
| K220472 | NEUWAVE Microwave Ablation System and Accessories | Aug 11, 2022 | Substantially Equivalent |
| K192427 | Ablation Confirmation | Oct 3, 2019 | Substantially Equivalent |
| K173756 | Certus 140 2.45GHz Ablation System | Oct 24, 2018 | Substantially Equivalent |
| K171022 | Ablation Confirmation | May 9, 2017 | Substantially Equivalent |
| K163118 | FLEX Microwave Ablation System and Accessories | Mar 9, 2017 | Substantially Equivalent |
| K161285 | Ablation Confirmation | Jun 29, 2016 | Substantially Equivalent |
| K160936 | Certus 140 2.45GHz Ablation System | May 4, 2016 | Substantially Equivalent |
| K150313 | Ablation Confirmation | Jul 9, 2015 | Substantially Equivalent |