FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FUJINON VIDEO LAPAROSCOPE, MODIFIED
K Number: K930297
·
Decision Mar 29, 1994
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
22
Applicant Total
30
Review Days
432
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 VIDEO LAPAROSCOPE, MODIFIED
- K Number
- K930297
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fujinon, Inc.
- Date Received
- January 21, 1993
- Decision Date
- March 29, 1994
- Product Code
- FWF
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FWF | Camera, Television, Endoscopic, Without Audio | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FWF), ordered by most recent decision date.
FLEXISCOPE, MODELS 50MH AND 50 MHC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VES 1501-M
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |