FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
K Number: K050907
·
Decision May 19, 2005
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
30
Review Days
38
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
- FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
- K Number
- K050907
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujinon, Inc.
- Date Received
- April 11, 2005
- Decision Date
- May 19, 2005
- Product Code
- EOQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EOQ), ordered by most recent decision date.
FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SmartClip Delivery Catheter (ADR-1715)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FUJIFILM Ultrasonic Endoscope EB-710US
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
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 |
| 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 |