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)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

ProVu

Device Name

Video Display Accessories

Model / Reference

038-990-015

FDA applicant

Flexicare Medical Limited.

Primary DI / UDI-DI

05055931112624

Basic UDI-DI

5055788700015503HB

510(k) Number

K250243 ↗

FDA Product Code

BTR

EMDN Code

Z12021004 Video laryngoscopes

Models / Variants

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)

Device Class

Class I EUDAMED

Class II 510(k)

Regulation

21 CFR Part 868.5730

EU market of registration

Germany

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Flexicare

  Class IIa

  CE/MDD

• Anaesthesia Circuits

  Class IIa

  CE/MDD

• Oxygen Therapy

  Class IIa

  CE/MDD

• Ventilator Circuits

  Class IIa

  CE/MDD

• Inteliflo

  Class IIa

  CE/MDD

• A2A Spacer

  Class IIb

  CE/MDD

See all devices from Flexicare Medical Limited →

• What sizes are available for the ProVu Single Use Video Stylet with Reinforced ET Tube, and how do I choose the right one for a patient?

  The ProVu Single Use Video Stylet with Reinforced ET Tube is available in four sizes: 6.5, 7.0, 7.5, and 8.0. The correct size is typically determined by the patient’s tracheal diameter, which is often estimated based on their height or age. For example, pediatric patients may require smaller sizes (e.g., 6.5 or 7.0), while adults generally need sizes 7.5 or 8.0. Always refer to clinical guidelines or consult with an anesthesiologist to ensure proper sizing for safe and effective intubation.

• Is the ProVu Single Use Video Stylet with Reinforced ET Tube designed for reuse, or is it intended for single-use only?

  The ProVu Single Use Video Stylet with Reinforced ET Tube is explicitly designed for single-use only. This design ensures patient safety by eliminating the risk of cross-contamination and maintaining sterility. After a single procedure, the device should be discarded, and a new sterile unit should be used for subsequent intubations.

• How is the ProVu Single Use Video Stylet with Reinforced ET Tube supplied, and what should I check before using it?

  The device is supplied sterile in a single-use packaging, ready for immediate clinical use. Before use, verify that the packaging is intact and undamaged to confirm sterility. Additionally, check the size label to ensure it matches the patient’s requirements, and inspect the reinforced endotracheal tube and video stylet for any visible defects or obstructions.

• What regulatory pathways does the ProVu Single Use Video Stylet with Reinforced ET Tube follow, and how does this affect its use?

  The device follows FDA 510(k) clearance and MDR (Medical Device Regulation) pathways, indicating it has undergone regulatory review for safety and performance. This means it meets established standards for tracheal tubes with connectors and video-assisted intubation systems. Clinicians can rely on its compliance with these frameworks, though local healthcare policies should always be consulted for specific procedural guidelines.

• What makes the reinforced endotracheal tube in this device different from standard tubes, and why is this important during intubation?

  The reinforced endotracheal tube in the ProVu device includes structural enhancements to improve durability and flexibility during intubation. This design helps prevent kinking or collapse, which can occur with standard tubes, especially in challenging intubation scenarios. The reinforcement also supports the video stylet’s positioning, aiding in accurate tracheal placement visualization and reducing the risk of complications during the procedure.