FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTEGRATED VISUALIZATION SYSTEM
K Number: K925108
·
Decision Jan 29, 1993
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
22
Applicant Total
23
Review Days
112
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Basic Information
- Device Name
- INTEGRATED VISUALIZATION SYSTEM
- K Number
- K925108
- 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
- Neuro Navigational Corp.
- Date Received
- October 9, 1992
- Decision Date
- January 29, 1993
- 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.
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EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
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ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
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VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
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VES 1501-M
FDA 510(k)
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Other Clearances by Neuro Navigational Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K965078 | 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS | Mar 6, 1997 | Substantially Equivalent |
| K961406 | NEUROVIEW SCISSORS | Jun 13, 1996 | Substantially Equivalent |
| K961173 | 1.2MM REUSABLE NEUROVIEW ENDOSCOPE | Jun 7, 1996 | Substantially Equivalent |
| K961300 | ASPIRATION/IRRIGATION CATHETER | Jun 7, 1996 | Substantially Equivalent |
| K960792 | DISPOSABLE NEUROVIEW INTRODUCER SHEATH | Apr 11, 1996 | Substantially Equivalent |
| K954938 | DISPOSABLE NEUROVIEW OPERATING SHEATH | Mar 7, 1996 | Substantially Equivalent |
| K955351 | NEUROVIEW COAXIAL BIPOLAR ELECTRODE | Feb 29, 1996 | Substantially Equivalent |
| K954899 | RIGID NEUROVIEW ENDOSCOPE | Dec 19, 1995 | Substantially Equivalent |
| K955467 | NEUROVIEW COAXIAL BIPOLAR ELECTRODE | Dec 18, 1995 | Substantially Equivalent |
| K955037 | RIGID NEUROVIEW ENDOSCOPE | Dec 4, 1995 | Substantially Equivalent for Some Indications |