FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX
K Number: K960915
·
Decision Dec 24, 1996
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
92
Applicant Total
22
Review Days
293
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Basic Information
- Device Name
- CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX
- K Number
- K960915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clarus Medical Systems, Inc.
- Date Received
- March 6, 1996
- Decision Date
- December 24, 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 Clarus Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | Aug 18, 1998 | Substantially Equivalent |
| K974579 | PERCSCOPE MODEL 2600 | Feb 18, 1998 | Substantially Equivalent |
| K971584 | CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) | May 23, 1997 | Substantially Equivalent |
| K971455 | CLARUS MODEL 5197 SIGHTLITE | May 20, 1997 | Substantially Equivalent |
| K962255 | CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) | Sep 11, 1996 | Substantially Equivalent |
| K955598 | CLARUS SPINEPEN MODEL 2126 | Feb 6, 1996 | Substantially Equivalent |
| K953685 | INSTRUMENT SCOPE | Oct 12, 1995 | Substantially Equivalent |
| K945633 | NEURO CHANNEL ENDOSCOPE MODEL 2232 | Sep 19, 1995 | Substantially Equivalent |
| K945296 | CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 | Jul 14, 1995 | Substantially Equivalent |
| K940144 | CLARUS PHOENIX ENDOSCOPE | Apr 25, 1995 | Substantially Equivalent |