Medical Device Manufacturer · CN , Shenzhen

Shenzhen Sanping Image Technology Co., Ltd.

2 submissions · 2 cleared · Since 2025
2
Total
2
Cleared
0
Denied

Shenzhen Sanping Image Technology Co., Ltd. — FDA 510(k) Submissions

Shenzhen Sanping Image Technology Co., Ltd. has submitted 2 FDA 510(k) premarket notifications since 2025, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bronchoscope (flexible Or Rigid), Ureteroscope And Accessories, Flexible/rigid . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
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)
K250917 · FGB Ureteroscope And... · Gastroenterology & Urology
Oct 2025 218d
Bronchoscope System,?The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)
K242010 · EOQ Bronchoscope (flexible Or... · Ear, Nose, Throat
Mar 2025 247d
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All2 Ear, Nose, Throat 1 Gastroenterology & Urology 1