Endoscopic Video Image Processor, Single-Use Video Hysteroscope
K-Number: K232003 · 2024-02-12
Decision Date2024-02-12
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Endoscopic Video Image Processor, Single-Use Video Hysteroscope is a medical device manufactured by Guangzhou Red Pine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-02-12 under approval number K232003. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Endoscopic Video Image Processor, Single-Use Video Hysteroscope?
Endoscopic Video Image Processor, Single-Use Video Hysteroscope is a medical device that received FDA 510(k) clearance on 2024-02-12. It is manufactured by Guangzhou Red Pine Medical Instrument Co., Ltd.. The 510(k) number is K232003.
When was Endoscopic Video Image Processor, Single-Use Video Hysteroscope approved by the FDA?
Endoscopic Video Image Processor, Single-Use Video Hysteroscope received FDA 510(k) clearance on 2024-02-12, under approval number K232003.
What company makes Endoscopic Video Image Processor, Single-Use Video Hysteroscope?
Endoscopic Video Image Processor, Single-Use Video Hysteroscope is manufactured by Guangzhou Red Pine Medical Instrument Co., Ltd..
What is the FDA product code for Endoscopic Video Image Processor, Single-Use Video Hysteroscope?
The FDA product code for Endoscopic Video Image Processor, Single-Use Video Hysteroscope is HIH.
Related Clinical Trials
NCT07557589
Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 Months
RECRUITING
NCT07595835
CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer
RECRUITING
NCT07033130
The Performance of Different Sound Paths in Adult NeuroZti CI-users
TERMINATED
NCT06921265
Targeted Transcranial Magnetic Stimulation to Improve Language and Speech in Patients With Primary Progressive Aphasia
ENROLLING_BY_INVITATION
NCT07557147
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
NOT_YET_RECRUITING
NCT04488224
Nano-X Image Guidance: CBCT With Gravity-induced Motion
WITHDRAWN
Other Devices by Guangzhou Red Pine Medical Instrument Co., Ltd.
K221158Single-Use Video Flexible Ureterorenoscope System
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)
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: HIH)
K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc.
K160751Symphion Endoscope and Symphion Cervical SheathBoston Scientific
K160510MAKO 7Nvision Medical Corporation
K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc.
K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc.
K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.
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.