Single-Use Video Flexible Ureterorenoscope System
K-Number: K221158 · 2023-03-06
Decision Date2023-03-06
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Single-Use Video Flexible Ureterorenoscope System is a medical device manufactured by Guangzhou Red Pine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-03-06 under approval number K221158. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Single-Use Video Flexible Ureterorenoscope System?
Single-Use Video Flexible Ureterorenoscope System is a medical device that received FDA 510(k) clearance on 2023-03-06. It is manufactured by Guangzhou Red Pine Medical Instrument Co., Ltd.. The 510(k) number is K221158.
When was Single-Use Video Flexible Ureterorenoscope System approved by the FDA?
Single-Use Video Flexible Ureterorenoscope System received FDA 510(k) clearance on 2023-03-06, under approval number K221158.
What company makes Single-Use Video Flexible Ureterorenoscope System?
Single-Use Video Flexible Ureterorenoscope System is manufactured by Guangzhou Red Pine Medical Instrument Co., Ltd..
What is the FDA product code for Single-Use Video Flexible Ureterorenoscope System?
The FDA product code for Single-Use Video Flexible Ureterorenoscope System is FGB.
Related Clinical Trials
NCT07475091
Standardizing Swallow Pressure Measurements
NOT_YET_RECRUITING
NCT01174108
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
RECRUITING
NCT03331380
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
RECRUITING
NCT03736226
A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China
ACTIVE_NOT_RECRUITING
NCT07608939
Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers
NOT_YET_RECRUITING
NCT07444320
Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System
RECRUITING
Related PubMed Literature
Other Devices by Guangzhou Red Pine Medical Instrument Co., Ltd.
K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
K240663Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)
K232003Endoscopic Video Image Processor, Single-Use Video Hysteroscope
K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)
Related Devices (Code: FGB)
K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.
K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd.
K181977WiScope Digital Endoscope SystemOTU Medical, Inc.
K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd.
K172246OLYMPUS URF-V2/V2ROlympus Medical Systems Corp.
K172298OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.