FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER LED LIGHTSOURCE
K Number: K082813
·
Decision Dec 19, 2008
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
30
Applicant Total
124
Review Days
86
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Basic Information
- Device Name
- STRYKER LED LIGHTSOURCE
- K Number
- K082813
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Corp.
- Date Received
- September 24, 2008
- Decision Date
- December 19, 2008
- 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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