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.
Summary
Flexicare Medical Limited filed four ProVu items under product code EOQ (Bronchoscope (Flexible Or Rigid)): 3.8mm Slim (090-02-0038U), 5.0mm Regular (090-02-0050U), and 6.0mm Large (090-02-0060U) Video Bronchoscopes, plus the ProVu Video Bronchoscope 8 display (040-07-0082U).
Class II, 21 CFR 874.4680. Ear, Nose, Throat is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Flexicare filed from Rhondda Cynon Taf, United Kingdom. The decision came 260 calendar days after FDA received it (December 16, 2025 to September 2, 2026).
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
- Product 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.