FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABLATE-IQ
K Number: K232227
·
Decision Apr 4, 2024
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
15
Review Days
252
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Basic Information
- Device Name
- ABLATE-IQ
- K Number
- K232227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neuwave Medical, Inc.
- Date Received
- July 27, 2023
- Decision Date
- April 4, 2024
- Product Code
- JAK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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Other Clearances by Neuwave Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231738 | NEUWAVE Microwave Ablation System and Accessories | Nov 16, 2023 | Substantially Equivalent |
| K220472 | NEUWAVE Microwave Ablation System and Accessories | Aug 11, 2022 | Substantially Equivalent |
| K200081 | NEUWAVE Microwave Ablation System and Accessories | Nov 13, 2020 | 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 |