AMT Low-Profile Suprapubic Catheter & Drainage Set
Summary
Applied Medical Technology, Inc. received 510(k) clearance for AMT Low-Profile Suprapubic Catheter & Drainage Set, a KOB device. Cleared on 2024-11-01.
Details
Source
510(k) Clearance
External ID
K240514
Action Date
2024-11-01
Status
Traditional
Category
device
Product Code
KOB
Product Description
AMT Low-Profile Suprapubic Catheter & Drainage Set. Product code: KOB.
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. Applied Medical Technology, Inc. has received 4 total clearances in our database.
Applied Medical Technology, Inc. has 15 FDA actions in our database, including 11 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 Applied Medical Technology, Inc. have FDA actions?
Applied Medical Technology, Inc. has 15 FDA actions in our database, including 11 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K240514" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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