Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe
Summary
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. received 510(k) clearance for Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe, a MEG device. Cleared on 2021-10-18.
Details
Source
510(k) Clearance
External ID
K211555
Action Date
2021-10-18
Status
Traditional
Category
device
Product Code
MEG
Product Description
Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe. Product code: MEG.
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. Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. has received 9 total clearances in our database.
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. has 9 FDA actions in our database, including 9 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 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. have FDA actions?
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. has 9 FDA actions in our database, including 0 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K211555" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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