FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASPIRATION/IRRIGATION CATHETER
K Number: K961300
·
Decision Jun 7, 1996
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
92
Applicant Total
23
Review Days
64
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Basic Information
- Device Name
- ASPIRATION/IRRIGATION CATHETER
- K Number
- K961300
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Neuro Navigational Corp.
- Date Received
- April 4, 1996
- Decision Date
- June 7, 1996
- Product Code
- GWG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWG | Endoscope, Neurological | FDA class 2 | Neurology |
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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 |
| 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 |
| K952639 | DISPOSABLE TOOTHED GRASPING FORCEP | Sep 8, 1995 | Substantially Equivalent |