Rusch Easy Tube
FDA 510(k) K043205 · Teleflex Medical
510(k) numberK043205
Submission
- Device name
- Rusch Easy Tube
- Applicant
- Teleflex Medical
Bannockburn, IL, US - Received
- November 19, 2004
- Decision date
- January 7, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5730
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K253437 | Spiro-VISTABTR · Traditional | Spiro Robotics | 06/12/2026SE |
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| K242495 | LMA Fastrach ETT SUBTR · Traditional | Teleflex Medical | 04/29/2025SE |
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch…BTR · Traditional | Teleflex Incorporated | 02/11/2025SE |
| K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440…BTR · Traditional | Covidien, LLC | 05/20/2024SE |
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Questions and answers
When was Rusch Easy Tube cleared by the FDA?
Rusch Easy Tube (K043205) received a 510(k) decision of Substantially Equivalent on January 7, 2005, 49 days after the submission was received.
What is the product code of K043205?
The FDA product code is BTR – Tube, Tracheal (W/Wo Connector), a Class II (moderate risk) device regulated under 21 CFR 868.5730.