FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)
K Number: K854907
·
Decision Jan 24, 1986
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
10
Applicant Total
24
Review Days
46
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Basic Information
- Device Name
- PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)
- K Number
- K854907
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Angiomed U.S., Inc.
- Date Received
- December 9, 1985
- Decision Date
- January 24, 1986
- Product Code
- GBO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBO), ordered by most recent decision date.
MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
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URESIL GENERAL PURPOSE DRAINAGE CATHETER
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PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)
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PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K864225 | ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT | Jan 30, 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 |