Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160,
Summary
Speciality Fibres and Materials, Ltd. received 510(k) clearance for Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch, a FRO device. Cleared on 2024-10-21.
Details
Source
510(k) Clearance
External ID
K222740
Action Date
2024-10-21
Status
Traditional
Category
device
Product Code
FRO
Product Description
Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch. Product code: FRO.
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.
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 Speciality Fibres and Materials, Ltd. have FDA actions?
This is the only FDA action we have on record for Speciality Fibres and Materials, Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K222740" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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