NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
Summary
Medtronic Xomed, Inc. received 510(k) clearance for NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube, a ETN device. Cleared on 2023-10-26.
Details
Source
510(k) Clearance
External ID
K230320
Action Date
2023-10-26
Status
Special
Category
device
Product Code
ETN
Product Description
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube. Product code: ETN.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Medtronic Xomed, Inc. has received 4 total clearances in our database.
Medtronic Xomed, Inc. has 19 FDA actions in our database, including 15 recalls and 4 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Medtronic Xomed, Inc. have FDA actions?
Medtronic Xomed, Inc. has 19 FDA actions in our database, including 15 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230320" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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