FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URETHRAL BALLOON DILATION CATHETER SET
K Number: K892855
·
Decision Nov 17, 1989
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
26
Applicant Total
104
Review Days
213
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Basic Information
- Device Name
- URETHRAL BALLOON DILATION CATHETER SET
- K Number
- K892855
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cook Urological, Inc.
- Date Received
- April 18, 1989
- Decision Date
- November 17, 1989
- Product Code
- KOE
- 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 |
|---|---|---|---|
| KOE | Dilator, Urethral | FDA class 2 | Gastroenterology, Urology |
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| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Nov 20, 2007 | Substantially Equivalent |
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