FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Colibri Endoscopy System
K Number: K192305
·
Decision Feb 27, 2020
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
161
Applicant Total
4
Review Days
188
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Basic Information
- Device Name
- Colibri Endoscopy System
- K Number
- K192305
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3nt Medical , Ltd.
- Date Received
- August 23, 2019
- Decision Date
- February 27, 2020
- Product Code
- EOB
- 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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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