Atlas FDA

RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY

FDA 510(k) clearance K961837 · decided 1996-08-16

Clearance details

K-number
K961837
Device name
RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY
Applicant
Rusch Intl.
Decision
Substantially Equivalent
Date received
1996-05-13
Decision date
1996-08-16
Days to decision
95 days
Clearance type
Traditional
Product code
BTR
Device class
2
Regulation number
868.5730
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Jeffrey, NH, US
Third-party review
No
Expedited review
No

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RecordFirmDate
Spiro-VISTA (K253437)Spiro Robotics2026-06-12
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AeroJet Ventilation Catheter (K243579)Pipeline Medical Products, LLC2025-08-13
Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) (K251499)William Cook Europe Aps2025-06-11
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
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504550 recall (Z-1845-2023)TELEFLEX LLC2023-06-29
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555 recall (Z-1846-2023)TELEFLEX LLC2023-06-29
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560 recall (Z-1847-2023)TELEFLEX LLC2023-06-29
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565 recall (Z-1848-2023)TELEFLEX LLC2023-06-29
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570 recall (Z-1849-2023)TELEFLEX LLC2023-06-29
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575 recall (Z-1850-2023)TELEFLEX LLC2023-06-29
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504580 recall (Z-1851-2023)TELEFLEX LLC2023-06-29
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585 recall (Z-1852-2023)TELEFLEX LLC2023-06-29
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504590 recall (Z-1853-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080055 recall (Z-1881-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095 recall (Z-1882-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100 recall (Z-1883-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050 recall (Z-1884-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055 recall (Z-1885-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060 recall (Z-1886-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065 recall (Z-1887-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070 recall (Z-1888-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075 recall (Z-1889-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080 recall (Z-1890-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085 recall (Z-1891-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090 recall (Z-1892-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095 recall (Z-1893-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100 recall (Z-1894-2023)TELEFLEX LLC2023-06-29
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480045 recall (Z-1899-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050 recall (Z-1958-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060 recall (Z-1959-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065 recall (Z-1960-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070 recall (Z-1961-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075 recall (Z-1962-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080 recall (Z-1963-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080085 recall (Z-1964-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080090 recall (Z-1965-2023)TELEFLEX LLC2023-06-29
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Styl recall (Z-1011-2023)TELEFLEX LLC2023-01-23