Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
Summary
Itp Innovative Tomography Products GmbH received 510(k) clearance for Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM, a KNW device. Cleared on 2024-06-18.
Details
Source
510(k) Clearance
External ID
K233294
Action Date
2024-06-18
Status
Traditional
Category
device
Product Code
KNW
Product Description
Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM. Product code: KNW.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 534 device clearances issued this month. Itp Innovative Tomography Products GmbH has received 2 total clearances in our database.
Itp Innovative Tomography Products GmbH has 2 FDA actions in our database, including 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 Itp Innovative Tomography Products GmbH have FDA actions?
Itp Innovative Tomography Products GmbH has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K233294" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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