FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Philips BlueControl
K Number: K171055
·
Decision Jul 6, 2017
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
6
Applicant Total
2
Review Days
87
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Basic Information
- Device Name
- Philips BlueControl
- K Number
- K171055
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Electronics Nederland B.V.
- Date Received
- April 10, 2017
- Decision Date
- July 6, 2017
- Product Code
- ONE
- 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 |
|---|---|---|---|
| ONE | Powered Light Based Non-Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Philips Electronics Nederland B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K192259 | Philips IntelliSite Pathology Solution | Sep 20, 2019 | Substantially Equivalent |