FDA 510(k)
FDA unclassified
Unknown
🇺🇸 United States
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
K Number: K191498
·
Decision Jan 29, 2020
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
55
Applicant Total
175
Review Days
238
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Basic Information
- Device Name
- Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
- K Number
- K191498
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- June 5, 2019
- Decision Date
- January 29, 2020
- Product Code
- LJE
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LJE | Catheter, Nephrostomy | FDA unclassified | Unknown |
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