FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WILTEK BALLOON STONE EXTRACTOR
K Number: K894865
·
Decision Dec 21, 1989
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
37
Applicant Total
21
Review Days
143
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Basic Information
- Device Name
- WILTEK BALLOON STONE EXTRACTOR
- K Number
- K894865
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Wiltek Medical, Inc.
- Date Received
- July 31, 1989
- Decision Date
- December 21, 1989
- Product Code
- LQR
- 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 |
|---|---|---|---|
| LQR | Dislodger, Stone, Biliary | 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 |
| K914881 | WILTEK LAPAROSCOPIC 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 |
| K912122 | CHOLANGIOGRAPHY CATHETER | Sep 23, 1991 | Substantially Equivalent |
| K912288 | WILTEK STANDARD CHOLANGIOGRAPHY CATHETER | Sep 23, 1991 | Substantially Equivalent |
| K910334 | ELECTROCAUTERY PROBE | Feb 21, 1991 | Substantially Equivalent |