FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BILIARY STENT
K Number: K943143
·
Decision Feb 28, 1995
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
31
Review Days
243
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
- BILIARY STENT
- K Number
- K943143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Menlo Care, Inc.
- Date Received
- June 30, 1994
- Decision Date
- February 28, 1995
- 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 Menlo Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964447 | PICC CATHETER/MIDLINE CATHETER | Apr 16, 1997 | Substantially Equivalent |
| K951620 | MIDMARK MIDLINE CATHETER | Apr 4, 1996 | Substantially Equivalent |
| K945521 | CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY | Apr 6, 1995 | Substantially Equivalent |
| K944968 | LANDMARK MIDLINE CATHETER | Mar 29, 1995 | Substantially Equivalent |
| K950737 | LANDMARK MIDLINE CATHETER | Mar 29, 1995 | Substantially Equivalent |
| K943893 | PERCUTANEOUS GRAINAGE CATHETER | Mar 7, 1995 | Substantially Equivalent |
| K930048 | SAFE-PICC CATHETER | May 12, 1994 | Substantially Equivalent |
| K933941 | MENLO CARE URINARY DIVERSION STENT | Mar 31, 1994 | Substantially Equivalent |
| K940127 | CENTERMARK SECURING WINGS | Feb 9, 1994 | Substantially Equivalent |
| K923394 | MENLO CARE AQUASTENT SET | Nov 16, 1993 | Substantially Equivalent |