510(k) clearance
3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)
- 510(k) number
- K254026
- Applicant
- Flexicare Medical Limited.
- Decision date
- Sep 2, 2026
- Date received
- Dec 16, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- EOQ
- Device type
- Bronchoscope (Flexible Or Rigid)
- Device class
- Class II
- Regulation
- 21 CFR 874.4680
- Advisory committee
- Ear, Nose, Throat
- Statement or summary
- Summary
- Third party
- N
- Location
- Rhondda Cynon Taf, GB