3.8mm Slim ProVu Video Bronchoscope (090-02-0038U) +3 more— 510(k) K254026
Substantially EquivalentFlexicare Medical Limited.
FDA 510(k) clearance K254026 for 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U) +3 more, Substantially Equivalent on 2026-09-02. Applicant: Flexicare Medical Limited.. Device class: 2.
Clearance details
- Device name as filed
- 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)
- Applicant
- Flexicare Medical Limited.
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rhondda Cynon Taf, GB
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Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.