FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Biopsy Refill Needle
K Number: K212819
·
Decision Jul 6, 2022
Classifications
1
FEI Numbers
128
Registration Numbers
128
Same Product Code
132
Applicant Total
4
Review Days
306
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Basic Information
- Device Name
- Disposable Biopsy Refill Needle
- K Number
- K212819
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suzhou Leapmed Healthcare Corporation
- Date Received
- September 3, 2021
- Decision Date
- July 6, 2022
- Product Code
- FCG
- 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 |
|---|---|---|---|
| FCG | Biopsy Needle | FDA class 2 | Gastroenterology, Urology |
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