FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC
K Number: K922881
·
Decision Nov 16, 1992
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
22
Review Days
153
Basic Information
- Device Name
- CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC
- K Number
- K922881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- CLARUS MEDICAL SYSTEMS, INC.
- Date Received
- June 16, 1992
- Decision Date
- November 16, 1992
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by CLARUS MEDICAL SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |