Vented Vial Adapter 20mm
Summary
West Pharma. Services IL, Ltd. received 510(k) clearance for Vented Vial Adapter 20mm, a LHI device. Cleared on 2022-08-31.
Details
Source
510(k) Clearance
External ID
K213513
Action Date
2022-08-31
Status
Traditional
Category
device
Product Code
LHI
Product Description
Vented Vial Adapter 20mm. Product code: LHI.
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. West Pharma. Services IL, Ltd. has received 5 total clearances in our database.
West Pharma. Services IL, Ltd. 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 West Pharma. Services IL, Ltd. have FDA actions?
West Pharma. Services IL, Ltd. 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 "K213513" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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