FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter
K Number: K180738
·
Decision Jun 14, 2018
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
81
Applicant Total
3
Review Days
84
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Basic Information
- Device Name
- COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter
- K Number
- K180738
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Compactcath, Inc.
- Date Received
- March 22, 2018
- Decision Date
- June 14, 2018
- Product Code
- EZD
- 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 |
|---|---|---|---|
| EZD | Catheter, Straight | FDA class 2 | Gastroenterology, Urology |
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