Atlas FDA

Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)

FDA 510(k) clearance K252468 · decided 2025-12-16

Clearance details

K-number
K252468
Device name
Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)
Applicant
Zhejiang Geyi Medical Instrument Co., Ltd.
Decision
Substantially Equivalent
Date received
2025-08-06
Decision date
2025-12-16
Days to decision
132 days
Clearance type
Traditional
Product code
FGB
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Jiande City, CN
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.