FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ZIP CONDOM CATHETER
K Number: K964219
·
Decision Aug 11, 1997
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
13
Applicant Total
1
Review Days
293
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Basic Information
- Device Name
- ZIP CONDOM CATHETER
- K Number
- K964219
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Goulter Medical, Inc.
- Date Received
- October 22, 1996
- Decision Date
- August 11, 1997
- Product Code
- EYZ
- 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 |
|---|---|---|---|
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | FDA class 1 | Gastroenterology, Urology |
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