Cleared Traditional

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. · Anesthesiology
May 2025
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K250243 is an FDA 510(k) clearance for the 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), a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Flexicare Medical Limited. (Rhondda Cynon Taf, GB). The FDA issued a Cleared decision on May 20, 2025, 113 days after receiving the submission on January 27, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K250243 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2025
Decision Date May 20, 2025
Days to Decision 113 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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