Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope,
Summary
Shenzhen Sanping Image Technology Co., Ltd. received 510(k) clearance for Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8), a FGB device. Cleared on 2025-10-31.
Details
Source
510(k) Clearance
External ID
K250917
Action Date
2025-10-31
Status
Traditional
Category
device
Product Code
FGB
Product Description
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8). Product code: FGB.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 389 device clearances issued this month. Shenzhen Sanping Image Technology Co., Ltd. has received 2 total clearances in our database.
Shenzhen Sanping Image Technology Co., Ltd. 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 Shenzhen Sanping Image Technology Co., Ltd. have FDA actions?
Shenzhen Sanping Image Technology Co., Ltd. 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 "K250917" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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