Colibri Endoscopy System
FDA 510(k) clearance K192305 · decided 2020-02-27
Clearance details
- K-number
- K192305
- Device name
- Colibri Endoscopy System
- Applicant
- 3nt Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-23
- Decision date
- 2020-02-27
- Days to decision
- 188 days
- Clearance type
- Special
- Product code
- EOB
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Rosh Ha'Ayin, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.