FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE
K Number: K932259
·
Decision Dec 15, 1993
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
55
Applicant Total
22
Review Days
239
Basic Information
- Device Name
- CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE
- K Number
- K932259
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4770
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CLARUS MEDICAL SYSTEMS, INC.
- Date Received
- April 20, 1993
- Decision Date
- December 15, 1993
- Product Code
- ERA
- 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 |
|---|---|---|---|
| ERA | Otoscope | FDA class 1 | Ear, Nose, Throat |
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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 |
| K960915 | CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX | Dec 24, 1996 | 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 |