FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILLUMINATED MEDIASTINOSCOPE
K Number: K141622
·
Decision Jan 9, 2015
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
10
Applicant Total
2
Review Days
206
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Basic Information
- Device Name
- ILLUMINATED MEDIASTINOSCOPE
- K Number
- K141622
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4720
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aegis Surgical, Ltd.
- Date Received
- June 17, 2014
- Decision Date
- January 9, 2015
- Product Code
- EWY
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EWY | Mediastinoscope, Surgical | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EWY), ordered by most recent decision date.
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OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE
FDA 510(k)
FDA Class 2
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Other Clearances by Aegis Surgical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K160171 | Illuminated Mediastinal Access Port | Feb 26, 2016 | Substantially Equivalent |