Logic Hd camera head green, System green
Summary
Richard Wolf Medical Instruments Corporation received 510(k) clearance for Logic Hd camera head green, System green, a FET device. Cleared on 2022-06-14.
Details
Source
510(k) Clearance
External ID
K212808
Action Date
2022-06-14
Status
Traditional
Category
device
Product Code
FET
Product Description
Logic Hd camera head green, System green. Product code: FET.
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. Richard Wolf Medical Instruments Corporation has received 3 total clearances in our database.
Richard Wolf Medical Instruments Corporation has 3 FDA actions in our database, including 3 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 Richard Wolf Medical Instruments Corporation have FDA actions?
Richard Wolf Medical Instruments Corporation has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212808" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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