FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
K Number: K182695
·
Decision Jun 17, 2019
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
27
Applicant Total
175
Review Days
263
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Basic Information
- Device Name
- Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
- K Number
- K182695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- September 27, 2018
- Decision Date
- June 17, 2019
- Product Code
- EYB
- 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 |
|---|---|---|---|
| EYB | Catheter, Ureteral, Gastro-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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