FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
K Number: K173657
·
Decision Aug 23, 2018
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
127
Applicant Total
175
Review Days
267
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Basic Information
- Device Name
- Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
- K Number
- K173657
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- November 29, 2017
- Decision Date
- August 23, 2018
- Product Code
- EZL
- 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 |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | FDA class 2 | Gastroenterology, Urology |
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