Atlas FDA

FLEXICARE MEDICAL ENDOTRACHEAL TUBES

FDA 510(k) clearance K091591 · decided 2009-06-17

Clearance details

K-number
K091591
Device name
FLEXICARE MEDICAL ENDOTRACHEAL TUBES
Applicant
Flexicare Medical, Ltd.
Decision
Substantially Equivalent
Date received
2009-06-02
Decision date
2009-06-17
Days to decision
15 days
Clearance type
Traditional
Product code
BTR
Device class
2
Regulation number
868.5730
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Mid Glamorgan, GB
Third-party review
Yes
Expedited review
No

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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) (K250243)Flexicare Medical Limited.2025-05-20
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Recalls involving this device

RecordFirmDate
ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7. recall (Z-0497-2021)Flexicare Medical Ltd.2020-11-26