Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
Summary
FUJIFILM Healthcare Americas Corporation received 510(k) clearance for Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L), a ITX device. Cleared on 2023-12-13.
Details
Source
510(k) Clearance
External ID
K231666
Action Date
2023-12-13
Status
Traditional
Category
device
Product Code
ITX
Product Description
Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L). Product code: ITX.
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. FUJIFILM Healthcare Americas Corporation has received 13 total clearances in our database.
FUJIFILM Healthcare Americas Corporation has 36 FDA actions in our database, including 23 recalls and 13 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 FUJIFILM Healthcare Americas Corporation have FDA actions?
FUJIFILM Healthcare Americas Corporation has 36 FDA actions in our database, including 23 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231666" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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