Promisemed Sharps container
Summary
Promisemed Hangzhou Meditech Co., Ltd. received 510(k) clearance for Promisemed Sharps container, a MMK device. Cleared on 2021-11-17.
Details
Source
510(k) Clearance
External ID
K211890
Action Date
2021-11-17
Status
Traditional
Category
device
Product Code
MMK
Product Description
Promisemed Sharps container. Product code: MMK.
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. Promisemed Hangzhou Meditech Co., Ltd. has received 25 total clearances in our database.
Promisemed Hangzhou Meditech Co., Ltd. has 25 FDA actions in our database, including 25 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 Promisemed Hangzhou Meditech Co., Ltd. have FDA actions?
Promisemed Hangzhou Meditech Co., Ltd. has 25 FDA actions in our database, including 0 recalls and 25 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K211890" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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