Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
Summary
Shanghai SeeGen Photoelectric Technology Co., Ltd. received 510(k) clearance for Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U), a FBN device. Cleared on 2025-03-07.
Details
Source
510(k) Clearance
External ID
K243535
Action Date
2025-03-07
Status
Special
Category
device
Product Code
FBN
Product Description
Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U). Product code: FBN.
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. Shanghai SeeGen Photoelectric Technology Co., Ltd. has received 4 total clearances in our database.
Shanghai SeeGen Photoelectric Technology Co., Ltd. has 4 FDA actions in our database, including 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 Shanghai SeeGen Photoelectric Technology Co., Ltd. have FDA actions?
Shanghai SeeGen Photoelectric Technology Co., Ltd. has 4 FDA actions in our database, including 0 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243535" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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