PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
Summary
Primed Medical Products, Inc. received 510(k) clearance for PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600), a FRG device. Cleared on 2024-05-24.
Details
Source
510(k) Clearance
External ID
K233777
Action Date
2024-05-24
Status
Traditional
Category
device
Product Code
FRG
Product Description
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600). Product code: FRG.
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. Primed Medical Products, Inc. has received 5 total clearances in our database.
Primed Medical Products, 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 Primed Medical Products, Inc. have FDA actions?
Primed Medical Products, 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 "K233777" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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