510(k) clearances

Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)

Teleflex Incorporated · Anesthesiology

K241451Substantially EquivalentTraditionalBTR
Open FDA's page for this record
Third party flag
N
City
Morrisville
Advisory committee description
Anesthesiology
Address 1
3015 Carrington Mills Blvd.
Address 2
Suite 600
Statement or summary
Summary
Product code
BTR
Zip code
27560
Applicant
Teleflex Incorporated
Decision date
2025-02-11
Decision code
SESE
Country code
US
Device name
Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)
Advisory committee
AN
Contact
Bouse Angela
K number
K241451
State
NC
Date received
2024-05-22
Review advisory committee
AN
Postal code
27560
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Tube, Tracheal (W/Wo Connector)
Medical specialty description
Anesthesiology
Regulation number
868.5730
Device class
2
Registration number
1526611, 3018094310, 3004056932, 3014479313, 1930870, 3009118476, 8041005, 3015058854, 3005382983, 3003674698, 8040412, 3004527595, 9616567, 1314417, 3005160810, 3021632375, 3005609751, 8021995, 3030412764, 3009050824, 3008439484, 3004111573, 3043226252, 2030598, 3011137372, 3041679947, 3006157842, 3006017180, 1420054, 8020889, 3043543260, 3011237770, 9612501, 3003903031, 3010131137, 2025816, 3027977504, 3010594263, 1220850, 3030733800 +96 more
FEI number
1526611, 3018094310, 3004056932, 3014479313, 1930870, 3009118476, 3015058854, 3005382983, 3002808507, 3003674698, 2523865, 3004527595, 1314417, 3005160810, 3021632375, 3005609751, 3030412764, 3009050824, 3008439484, 3004111573, 3043226252, 3041679947, 3006157842, 3006017180, 1420054, 1000138054, 3003076831, 3043543260, 3011237770, 3003903031, 3010131137, 2025816, 3027977504, 3002807626, 3010594263, 1000511237, 1220850, 3003382061, 1000113735, 3030733800 +96 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.