CINtec Histology
Summary
Ventana Medical Systems, Inc. received 510(k) clearance for CINtec Histology, a PRB device. Cleared on 2021-12-10.
Details
Source
510(k) Clearance
External ID
K212176
Action Date
2021-12-10
Status
Traditional
Category
device
Product Code
PRB
Product Description
CINtec Histology. Product code: PRB.
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. Ventana Medical Systems, Inc. has received 4 total clearances in our database.
Ventana Medical Systems, Inc. has 8 FDA actions in our database, including 4 recalls and 4 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 Ventana Medical Systems, Inc. have FDA actions?
Ventana Medical Systems, Inc. has 8 FDA actions in our database, including 4 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212176" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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