FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO
K Number: K851647
·
Decision Jul 3, 1985
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
24
Review Days
72
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
- OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO
- K Number
- K851647
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Meadox Surgimed, Inc.
- Date Received
- April 22, 1985
- Decision Date
- July 3, 1985
- 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 Meadox Surgimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944143 | MS CLASSIQUE BALLOON CATHETER | Mar 13, 1995 | Substantially Equivalent |
| K945061 | NOPROFILE OLBERT CATHETER SYSTEM | Mar 9, 1995 | Substantially Equivalent |
| K942382 | MS AMPLATZ EXTRA STIFF GUIDE WIRE | Aug 22, 1994 | Substantially Equivalent |
| K930201 | ACECUT SUTOMATIC BIOPSY SYSTEM | Jun 9, 1993 | Substantially Equivalent |
| K911635 | MEADOX(R) SURGIMED(R) BIOPSY GUN II | Jun 20, 1991 | Substantially Equivalent |
| K905181 | NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY | Mar 6, 1991 | Substantially Equivalent |
| K904582 | QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE | Feb 25, 1991 | Substantially Equivalent |
| K904983 | MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY | Jan 30, 1991 | Substantially Equivalent |
| K902461 | MEADOX SURGIMED BIOPSY GUN AND NEEDLE | Jul 16, 1990 | Substantially Equivalent |
| K890926 | SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE | Jun 20, 1989 | Substantially Equivalent |