Braun Silk.expert Mini
Summary
Cyden Limited received 510(k) clearance for Braun Silk.expert Mini, a OHT device. Cleared on 2021-07-28.
Details
Source
510(k) Clearance
External ID
K211994
Action Date
2021-07-28
Status
Special
Category
device
Product Code
OHT
Product Description
Braun Silk.expert Mini. Product code: OHT.
Company
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. Cyden Limited has received 6 total clearances in our database.
Cyden Limited has 6 FDA actions in our database, including 6 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 Cyden Limited have FDA actions?
Cyden Limited has 6 FDA actions in our database, including 0 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K211994" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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