FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
K Number: K012265
·
Decision Oct 17, 2001
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
30
Applicant Total
14
Review Days
90
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Basic Information
- Device Name
- METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
- K Number
- K012265
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Circon Video
- Date Received
- July 19, 2001
- Decision Date
- October 17, 2001
- Product Code
- FCW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCW | Light Source, Fiberoptic, Routine | FDA class 2 | Gastroenterology, Urology |
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| K012925 | DUR-8, MODELS DUR-8 | Nov 7, 2001 | Substantially Equivalent |
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| K970595 | CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP | Oct 24, 1997 | Substantially Equivalent |
| K914883 | CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG | Jan 15, 1993 | Substantially Equivalent |