Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
FDA 510(k) clearance K214063 · decided 2022-06-03
Clearance details
- K-number
- K214063
- Device name
- Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
- Applicant
- Guangzhou Shengwei Medical Devices Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-27
- Decision date
- 2022-06-03
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Conghua City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.