FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URETHRAL CATHETER
K Number: K800505
·
Decision Apr 8, 1980
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
9
Review Days
35
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Basic Information
- Device Name
- URETHRAL CATHETER
- K Number
- K800505
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Craft , Ltd.
- Date Received
- March 4, 1980
- Decision Date
- April 8, 1980
- Product Code
- KOD
- 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 |
|---|---|---|---|
| KOD | Catheter, Urological | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Medi-Craft , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K861949 | SUCTION CATHETER KIT | Oct 22, 1986 | Substantially Equivalent |
| K800508 | STOMACH TUBES | Apr 8, 1980 | Substantially Equivalent |
| K800510 | RECTAL & HARRIS FLUSH TUBES | Apr 8, 1980 | Substantially Equivalent |
| K800507 | FEEDING TUBES | Apr 8, 1980 | Substantially Equivalent |
| K800509 | CONNECTING TUBES | Mar 25, 1980 | Substantially Equivalent |
| K800506 | OXYGEN CATHETER | Mar 25, 1980 | Substantially Equivalent |
| K800503 | SUCTION CATHETER | Mar 18, 1980 | Substantially Equivalent |
| K800504 | OXYGEN CONNECTING TUBES | Mar 18, 1980 | Substantially Equivalent |