Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
FDA 510(k) clearance K152466 · decided 2016-05-19
Clearance details
- K-number
- K152466
- Device name
- Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
- Applicant
- Prosurg, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-31
- Decision date
- 2016-05-19
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.