BroncTru™ Transbronchial Access Tool
FDA 510(k) clearance K232601 · decided 2024-05-31
Clearance details
- K-number
- K232601
- Device name
- BroncTru™ Transbronchial Access Tool
- Applicant
- Broncus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-28
- Decision date
- 2024-05-31
- Days to decision
- 277 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.