FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER KNIFELIGHT
K Number: K100884
·
Decision Jun 25, 2010
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
28
Applicant Total
288
Review Days
87
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Basic Information
- Device Name
- STRYKER KNIFELIGHT
- K Number
- K100884
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica Osteonics Corp.
- Date Received
- March 30, 2010
- Decision Date
- June 25, 2010
- Product Code
- FTD
- 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 |
|---|---|---|---|
| FTD | Lamp, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTD), ordered by most recent decision date.
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
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POLARIS 100/200
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ATRICURE DISSECTOR
FDA 510(k)
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HM-LAMP II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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