FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT
K Number: K913294
·
Decision Oct 4, 1991
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
25
Applicant Total
11
Review Days
72
Basic Information
- Device Name
- SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT
- K Number
- K913294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Surgitek Medical Engineering Corp.
- Date Received
- July 24, 1991
- Decision Date
- October 4, 1991
- Product Code
- GCA
- 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 |
|---|---|---|---|
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCA), ordered by most recent decision date.
Disposable Stone Retrieval Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SpyGlass Discover Balloon Dilation Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Stone Retrieval Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Stone Retrieval Balloon
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Fusion Quattro Extraction Balloon
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Surgitek Medical Engineering Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K914504 | CYTOLOGY BRUSH | Feb 18, 1992 | Substantially Equivalent |
| K914495 | E.R.C.P. CATHETER | Jan 30, 1992 | Substantially Equivalent |
| K914497 | BIOPSY FORCEPS | Jan 3, 1992 | Substantially Equivalent |
| K914505 | STONE BASKET | Dec 9, 1991 | Substantially Equivalent |
| K914496 | SCLEROTHERAPY NEEDLE | Dec 5, 1991 | Substantially Equivalent |
| K914503 | GRASPING FORCEPS | Dec 5, 1991 | Substantially Equivalent |
| K913928 | SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT | Nov 19, 1991 | Substantially Equivalent |
| K910769 | SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM | Jun 25, 1991 | Substantially Equivalent |
| K910768 | SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE | Mar 19, 1991 | Substantially Equivalent |
| K903127 | SURGITEK(R) TURP MONITOR | Oct 9, 1990 | Substantially Equivalent |