FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K Number: K914881
·
Decision Jan 7, 1992
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
464
Applicant Total
21
Review Days
69
Basic Information
- Device Name
- WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
- K Number
- K914881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- WILTEK MEDICAL, INC.
- Date Received
- October 30, 1991
- Decision Date
- January 7, 1992
- 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 WILTEK MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K990231 | WILTEK HOT BIOPSY FORCEPS | Apr 13, 1999 | Substantially Equivalent |
| K922989 | WILTEK IRRIGAITON/ASPIRATION TUBE SET | Feb 15, 1994 | Substantially Equivalent |
| K930419 | WILTEK BIOPSY FORCEPS | Jun 1, 1993 | Substantially Equivalent |
| K914882 | WILTEK BALLOON CHOLANGIOGRAPHY CATHETER | Jan 7, 1992 | Substantially Equivalent |
| K914132 | WILTEK ELECTROCAUTERY ACTIVE CORD | Sep 25, 1991 | Substantially Equivalent |
| K914131 | WILTEK ELECTROCAUTERY ADAPTOR | Sep 25, 1991 | Substantially Equivalent |
| K912288 | WILTEK STANDARD CHOLANGIOGRAPHY CATHETER | Sep 23, 1991 | Substantially Equivalent |
| K912122 | CHOLANGIOGRAPHY CATHETER | Sep 23, 1991 | Substantially Equivalent |
| K910334 | ELECTROCAUTERY PROBE | Feb 21, 1991 | Substantially Equivalent |
| K894871 | WILTEK BILIARY STENT SET | Dec 21, 1989 | Substantially Equivalent |