FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FUJINON STERILE OVERTUBES
K Number: K091773
·
Decision Aug 7, 2009
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
100
Applicant Total
30
Review Days
52
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Basic Information
- Device Name
- FUJINON STERILE OVERTUBES
- K Number
- K091773
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujinon, Inc.
- Date Received
- June 16, 2009
- Decision Date
- August 7, 2009
- Product Code
- FED
- 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 |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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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 |
| 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 |
| K042076 | FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 | Nov 18, 2004 | Substantially Equivalent |