FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URESIL GENERAL PURPOSE DRAINAGE CATHETER
K Number: K912109
·
Decision Aug 12, 1991
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
10
Applicant Total
45
Review Days
91
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Basic Information
- Device Name
- URESIL GENERAL PURPOSE DRAINAGE CATHETER
- K Number
- K912109
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Uresil Corp.
- Date Received
- May 13, 1991
- Decision Date
- August 12, 1991
- 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
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PERCUTANEOUS NEPHROSTOMY SETS (OTTO)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Uresil Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K003753 | GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE | Jan 4, 2001 | Substantially Equivalent |
| K980278 | URESIL VASCU-FLO INFUSION CATHETER | Nov 20, 1998 | Substantially Equivalent |
| K981344 | URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING | Sep 10, 1998 | Substantially Equivalent |
| K980282 | URESIL DILATOR WITH RADIOPAQUE MARKER | Apr 24, 1998 | Substantially Equivalent |
| K980889 | URESIL NEPHRO-URETERAL STENT | Apr 8, 1998 | Substantially Equivalent |
| K972582 | URESIL GUIDEWIRE | Nov 21, 1997 | Substantially Equivalent |
| K972583 | URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S | Aug 29, 1997 | Substantially Equivalent |
| K953923 | URESIL INTRODUCING NEEDLE | Sep 8, 1995 | Substantially Equivalent |
| K945934 | URESIL(R) GUIDEWIRE | Jul 10, 1995 | Substantially Equivalent |
| K942688 | NEPHRO-URETERAL STENT | Jun 6, 1995 | Substantially Equivalent |