FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇳 China
Ultrasonic Scalpel System
K Number: K212614
·
Decision Jul 18, 2022
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
156
Applicant Total
7
Review Days
334
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Basic Information
- Device Name
- Ultrasonic Scalpel System
- K Number
- K212614
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Date Received
- August 18, 2021
- Decision Date
- July 18, 2022
- Product Code
- LFL
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
Similar 510(k) Clearances
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CUSA® Clarity Ultrasonic Surgical Aspirator System
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Ultrasonic Surgical System
FDA 510(k)
FDA Unclassified
·Unknown
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 |
| 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 |
| K190052 | Radio Frequency Ablation System | Jun 25, 2019 | Substantially Equivalent |