Ahmed® Glaucoma Valve Model FP8
Summary
New World Medical, Inc. received 510(k) clearance for Ahmed® Glaucoma Valve Model FP8, a KYF device. Cleared on 2023-05-12.
Details
Source
510(k) Clearance
External ID
K231051
Action Date
2023-05-12
Status
Special
Category
device
Product Code
KYF
Product Description
Ahmed® Glaucoma Valve Model FP8. Product code: KYF.
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. New World Medical, Inc. has received 5 total clearances in our database.
New World Medical, Inc. has 5 FDA actions in our database, including 5 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 New World Medical, Inc. have FDA actions?
New World Medical, Inc. has 5 FDA actions in our database, including 0 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231051" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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