Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Nee
Summary
Jiangsu Micsafe Medical Technology Co., Ltd. received 510(k) clearance for Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single, a JKA device. Cleared on 2021-11-04.
Details
Source
510(k) Clearance
External ID
K212019
Action Date
2021-11-04
Status
Traditional
Category
device
Product Code
JKA
Product Description
Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single. Product code: JKA.
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 Jiangsu Micsafe Medical Technology Co., Ltd. have FDA actions?
This is the only FDA action we have on record for Jiangsu Micsafe Medical Technology Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212019" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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