FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E.R.C.P. CATHETER
K Number: K914495
·
Decision Jan 30, 1992
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
11
Review Days
114
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- E.R.C.P. CATHETER
- K Number
- K914495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgitek Medical Engineering Corp.
- Date Received
- October 8, 1991
- Decision Date
- January 30, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGE), ordered by most recent decision date.
Dilation Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endoflux Biliary & Pancreatic Stent Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BARE Wireguided Balloon Dilation Catheter (1235)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single use stone retrieval balloons
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
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 |
| 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 |
| K913294 | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT | Oct 4, 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 |