FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Radio Frequency Ablation System
K Number: K190052
·
Decision Jun 25, 2019
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
7
Review Days
165
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Basic Information
- Device Name
- Radio Frequency Ablation System
- K Number
- K190052
- 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
- Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Date Received
- January 11, 2019
- Decision Date
- June 25, 2019
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K240376 | Electroporation System (N3000) | Oct 4, 2024 | Substantially Equivalent |
| K221995 | Gas Insufflator | Mar 28, 2023 | Substantially Equivalent |
| K212614 | Ultrasonic Scalpel System | Jul 18, 2022 | Substantially Equivalent |
| K210488 | Ultrasonic Surgical & Electrosurgical Generator | Oct 25, 2021 | Substantially Equivalent |
| K210116 | Video Endoscopy System, 3D Video Endoscopy System | Oct 13, 2021 | Substantially Equivalent |
| K183153 | Microwave Ablation System | Jul 8, 2019 | Substantially Equivalent |