FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BILIARY INDWELLING STENT
K Number: K834351
·
Decision Mar 22, 1984
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
21
Review Days
100
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 INDWELLING STENT
- K Number
- K834351
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Hobbs Medical, Inc.
- Date Received
- December 13, 1983
- Decision Date
- March 22, 1984
- 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 Hobbs Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241874 | Aspiration Catheter (2189) | Sep 24, 2024 | Substantially Equivalent |
| K182927 | Pulmonary Cytology Brush | Feb 7, 2020 | Substantially Equivalent |
| K093079 | TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U | Aug 2, 2010 | Substantially Equivalent |
| K030765 | HOBBS MISTIFIER SPRAY CATHETER | Jun 9, 2003 | Substantially Equivalent |
| K933354 | HOBBS MEDICAL CLEANING BRUSH | Oct 28, 1993 | Substantially Equivalent |
| K922396 | FUJINON FORCEPS -- MODIFICATION | Dec 10, 1992 | Substantially Equivalent |
| K921026 | PRESSURE GAUGE | Apr 24, 1992 | Substantially Equivalent |
| K914358 | ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP | Nov 19, 1991 | Substantially Equivalent |
| K893729 | HOBBS MEDICAL MICROBIOLOGY BRUSH | Aug 28, 1989 | Substantially Equivalent |
| K872509 | LINDEN STONE EXTRACTION BALLOON | Sep 22, 1987 | Substantially Equivalent |