VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E
Summary
Vinno Technology (Suzhou) Co.,Ltd received 510(k) clearance for VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E, a IYN device. Cleared on 2023-06-23.
Details
Source
510(k) Clearance
External ID
K230160
Action Date
2023-06-23
Status
Traditional
Category
device
Product Code
IYN
Product Description
VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E. Product code: IYN.
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. Vinno Technology (Suzhou) Co.,Ltd has received 5 total clearances in our database.
Vinno Technology (Suzhou) Co.,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 Vinno Technology (Suzhou) Co.,Ltd have FDA actions?
Vinno Technology (Suzhou) Co.,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 "K230160" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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