FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LINEBERGER EXTERNAL MALE CATHETER
K Number: K800890
·
Decision Jun 20, 1980
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
205
Applicant Total
1
Review Days
63
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Basic Information
- Device Name
- LINEBERGER EXTERNAL MALE CATHETER
- K Number
- K800890
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Lineberger External Catheter Co.
- Date Received
- April 18, 1980
- Decision Date
- June 20, 1980
- Product Code
- KNX
- 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 |
|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | FDA class 2 | Gastroenterology, Urology |
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