Guangzhou Red Pine Medical ... — FDA 510(k) Submissions

Guangzhou Red Pine Medical Instrument Co., Ltd. — FDA 510(k) Submissions

Guangzhou Red Pine Medical Instrument Co., Ltd. has submitted 9 FDA 510(k) premarket notifications since 2023, of which 9 received clearance as substantially equivalent to a predicate device.

Single-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)

K251951 · FGB Ureteroscope And... · Gastroenterology & Urology

Dec 2025 174d

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

K252176 · FAJ Cystoscope And... · Gastroenterology & Urology

Aug 2025 28d

Endoscopic Video Image Processor (RP-IPD-V1000F)

K243321 · FET Endoscopic Video Imaging... · Gastroenterology & Urology

Feb 2025 107d

Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)

K241987 · HIH Hysteroscope (and... · Obstetrics & Gynecology

Aug 2024 25d

Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

K241500 · FAJ Cystoscope And... · Gastroenterology & Urology

Jul 2024 45d

Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)

K240663 · FAJ Cystoscope And... · Gastroenterology & Urology

Jun 2024 105d

Endoscopic 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)

K232043 · FDF Colonoscope And... · Gastroenterology & Urology

Feb 2024 221d

Endoscopic Video Image Processor, Single-Use Video Hysteroscope

K232003 · HIH Hysteroscope (and... · Obstetrics & Gynecology

Feb 2024 221d

Single-Use Video Flexible Ureterorenoscope System

K221158 · FGB Ureteroscope And... · Gastroenterology & Urology

Mar 2023 319d

Guangzhou Red Pine Medical Instrument Co., Ltd.

Guangzhou Red Pine Medical Instrument Co., Ltd. — FDA 510(k) Submissions

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