FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S
K Number: K972583
·
Decision Aug 29, 1997
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
45
Review Days
50
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Basic Information
- Device Name
- URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S
- K Number
- K972583
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Uresil Corp.
- Date Received
- July 10, 1997
- Decision Date
- August 29, 1997
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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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 |
| 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 |
| K944784 | MINI-OP LAPAROSCOPIC LASSO | Oct 28, 1994 | Substantially Equivalent |