FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Sclerotherapy Needle
K Number: K190032
·
Decision Feb 27, 2020
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
84
Applicant Total
3
Review Days
416
Basic Information
- Device Name
- Disposable Sclerotherapy Needle
- K Number
- K190032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hangzhou AGS MedTech CO., Ltd
- Date Received
- January 7, 2019
- Decision Date
- February 27, 2020
- Product Code
- FBK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FBK), ordered by most recent decision date.
EzVu Visual Vasopressor injector (EV-19)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endoscopic Injection Needles
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
injeTAK Adjustable Tip Needle (DIS199; DIS201)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Injection Needles
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Endoscope Injection Needles
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology