Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Endoscopic Video Image Processor, Single-Use Video Hysteroscope

K-Number: K232003 · 2024-02-12

ApplicantGuangzhou Red Pine Medical Instrument Co., Ltd.
Decision Date2024-02-12
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Endoscopic Video Image Processor, Single-Use Video Hysteroscope is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-02-12 under 510(k) 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. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. The 510(k) number is K232003.

When did Endoscopic Video Image Processor, Single-Use Video Hysteroscope receive FDA 510(k) clearance?

Endoscopic Video Image Processor, Single-Use Video Hysteroscope received FDA 510(k) clearance on 2024-02-12, under 510(k) number K232003.

Who is the listed applicant for Endoscopic Video Image Processor, Single-Use Video Hysteroscope?

The FDA 510(k) record lists Guangzhou Red Pine Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07557589Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 MonthsRECRUITING

Other records listing Guangzhou Red Pine Medical Instrument Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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)K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)K243321Endoscopic Video Image Processor (RP-IPD-V1000F)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)

View all 9 devices →

Related Devices (Code: HIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.K252012SPY Cystoscope/HysteroscopeStryker EndoscopyK243382RZ Resectoscope SystemRz Medizintechnik GmbH

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.

↑