FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Cystoject Syringe Lever
K Number: K203321
·
Decision Dec 9, 2020
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
5
Review Days
27
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Basic Information
- Device Name
- Cystoject Syringe Lever
- K Number
- K203321
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Urogen Pharma, Ltd.
- Date Received
- November 12, 2020
- Decision Date
- December 9, 2020
- Product Code
- QBL
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| QBL | Piston Syringe Lever | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QBL), ordered by most recent decision date.
Uroject12 Syringe Lever
FDA 510(k)
FDA Class 2
·General Hospital
Uroject12 Syringe Lever
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Urogen Pharma, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Nov 19, 2021 | Substantially Equivalent |
| K190987 | Uroject12 Syringe Lever | Dec 2, 2019 | Substantially Equivalent |
| K180354 | UroGen Ureteral Catheter | Oct 30, 2018 | Substantially Equivalent |
| K180345 | Uroject12 Syringe Lever | Oct 17, 2018 | Substantially Equivalent |