FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS
K Number: K855176
·
Decision May 13, 1986
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
88
Applicant Total
1
Review Days
138
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Basic Information
- Device Name
- TRANSURETHAL PROSTATOME DIAG TREATM PROPULSION SYS
- K Number
- K855176
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Urologic Surgical Devices Corp.
- Date Received
- December 26, 1985
- Decision Date
- May 13, 1986
- Product Code
- FBK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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