Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)
Summary
Ambu A/S received 510(k) clearance for Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection), a FAJ device. Cleared on 2025-06-11.
Details
Source
510(k) Clearance
External ID
K250269
Action Date
2025-06-11
Status
Traditional
Category
device
Product Code
FAJ
Product Description
Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection). Product code: FAJ.
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. Ambu A/S has received 15 total clearances in our database.
Ambu A/S has 15 FDA actions in our database, including 15 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 Ambu A/S have FDA actions?
Ambu A/S has 15 FDA actions in our database, including 0 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250269" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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