ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
Summary
Instrumentation Laboratory (IL) Co. received 510(k) clearance for ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS), a GKP device. Cleared on 2024-08-16.
Details
Source
510(k) Clearance
External ID
K242127
Action Date
2024-08-16
Status
Special
Category
device
Product Code
GKP
Product Description
ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS). Product code: GKP.
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. Instrumentation Laboratory (IL) Co. has received 4 total clearances in our database.
Instrumentation Laboratory (IL) Co. has 4 FDA actions in our database, including 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 Instrumentation Laboratory (IL) Co. have FDA actions?
Instrumentation Laboratory (IL) Co. has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K242127" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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