FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT
K Number: K864225
·
Decision Jan 30, 1987
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
121
Applicant Total
24
Review Days
94
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Basic Information
- Device Name
- ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT
- K Number
- K864225
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Angiomed U.S., Inc.
- Date Received
- October 28, 1986
- Decision Date
- January 30, 1987
- Product Code
- FAD
- 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 |
|---|---|---|---|
| FAD | Stent, Ureteral | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Angiomed U.S., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874771 | ANGIOMED INTRODUCING SETS | Jan 12, 1988 | Substantially Equivalent |
| K874585 | ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE | Dec 2, 1987 | Substantially Equivalent |
| K863386 | VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS | Oct 24, 1986 | Substantially Equivalent |
| K862805 | ANGIOMED VAC-U-CUT BIOPSY NEEDLE | Sep 29, 1986 | Substantially Equivalent |
| K863446 | ANGIOMED HIGH PRESSURE CONNECTORS | Sep 23, 1986 | Substantially Equivalent |
| K854910 | ANGIOFLOW | Jul 17, 1986 | Substantially Equivalent |
| K854912 | ANGIOMED GUIED WIRES | Apr 16, 1986 | Substantially Equivalent |
| K854908 | UROFLEX | Mar 14, 1986 | Substantially Equivalent |
| K855142 | ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY | Mar 11, 1986 | Substantially Equivalent |
| K855076 | ANGIOMED URETER DIATION SETS | Mar 11, 1986 | Substantially Equivalent |