FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
K Number: K211032
·
Decision Nov 19, 2021
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
5
Review Days
226
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Basic Information
- Device Name
- Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
- K Number
- K211032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Urogen Pharma, Ltd.
- Date Received
- April 7, 2021
- Decision Date
- November 19, 2021
- Product Code
- KOD
- 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 |
|---|---|---|---|
| KOD | Catheter, Urological | FDA class 2 | Gastroenterology, Urology |
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