FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
K Number: K214063
·
Decision Jun 3, 2022
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
1
Review Days
158
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Basic Information
- Device Name
- Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
- K Number
- K214063
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guangzhou Shengwei Medical Devices Co., Ltd.
- Date Received
- December 27, 2021
- Decision Date
- June 3, 2022
- Product Code
- KNW
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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