FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Flexible 19G EBUS Needle
K Number: K142909
·
Decision Apr 24, 2015
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
226
Applicant Total
3
Review Days
200
Basic Information
- Device Name
- Flexible 19G EBUS Needle
- K Number
- K142909
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SPIRATION, INC.
- Date Received
- October 6, 2014
- Decision Date
- April 24, 2015
- Product Code
- EOQ
- 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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