ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U) +3 more— 510(k) K250243
Substantially EquivalentFlexicare Medical Limited.
FDA 510(k) clearance K250243 for ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U) +3 more, Substantially Equivalent on 2025-05-20. Applicant: Flexicare Medical Limited.. Device class: 2.
Clearance details
- Device name as filed
- ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
- Applicant
- Flexicare Medical Limited.
- Product code
- Code BTR
- Device class
- Class 2
- Regulation
- 21 CFR 868.5730
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rhondda Cynon Taf, GB
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Adverse events under product code BTR
product code BTR- Death
- 92
- Injury
- 1,263
- Malfunction
- 7,475
- Other
- 2
- Total
- 8,832
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.