FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION
K Number: K933906
·
Decision Jul 8, 1994
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
42
Applicant Total
30
Review Days
331
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
- CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION
- K Number
- K933906
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujinon, Inc.
- Date Received
- August 11, 1993
- Decision Date
- July 8, 1994
- Product Code
- FBN
- 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 |
|---|---|---|---|
| FBN | Choledochoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FBN), ordered by most recent decision date.
Single-use Video Scope; PB Digital Controller
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable Distal Cap
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Biliary Pancreaticobiliary Scope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Fujinon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120446 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 | Aug 13, 2012 | Substantially Equivalent |
| K112391 | FUJINON COLONOSCOPES | Jul 26, 2012 | Substantially Equivalent |
| K102466 | FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR | May 25, 2011 | Substantially Equivalent |
| K111243 | FUJINON ULTRASONIC PROCESSOR | May 16, 2011 | Substantially Equivalent |
| K091773 | FUJINON STERILE OVERTUBES | Aug 7, 2009 | Substantially Equivalent |
| K090116 | FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 | Apr 22, 2009 | Substantially Equivalent |
| K063316 | FUJINON MODEL EG-530N TRANS NASAL INSERTION | Mar 16, 2007 | Substantially Equivalent |
| K063847 | FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 | Mar 1, 2007 | Substantially Equivalent |
| K050907 | FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P | May 19, 2005 | Substantially Equivalent |
| K042043 | FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 | Nov 24, 2004 | Substantially Equivalent |