Straumann Surgical Cassettes
Summary
Straumann USA, LLC received 510(k) clearance for Straumann Surgical Cassettes, a KCT device. Cleared on 2021-07-29.
Details
Source
510(k) Clearance
External ID
K203753
Action Date
2021-07-29
Status
Traditional
Category
device
Product Code
KCT
Product Description
Straumann Surgical Cassettes. Product code: KCT.
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. Straumann USA, LLC has received 2 total clearances in our database.
Straumann USA, LLC has 17 FDA actions in our database, including 15 recalls and 2 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 Straumann USA, LLC have FDA actions?
Straumann USA, LLC has 17 FDA actions in our database, including 15 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K203753" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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