FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Ureteral Access Sheath
K Number: K203165
·
Decision Apr 30, 2021
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
100
Applicant Total
1
Review Days
189
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Disposable Ureteral Access Sheath
- K Number
- K203165
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suzhou Beyo Medical Technology Co., Ltd.
- Date Received
- October 23, 2020
- Decision Date
- April 30, 2021
- Product Code
- FED
- 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 |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FED), ordered by most recent decision date.
CVAC Aspiration System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Prodeon Urethral Sheath System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Suction-Evacuation Ureteral Access Sheath
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ureteral Access Sheath
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single-use Ureteral Access Sheath
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology