Data / Medical devices / China / Guangzhou Red Pine Medical Instrument Co.,ltd.
Guangzhou Red Pine Medical Instrument Co.,ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 10 510(k) clearances
Guangzhou Red Pine Medical Instrument Co.,ltd. is registered with the FDA (registration 3021246306) in Guangzhou Guangdong, China. It lists 8 device types. The FDA files 10 510(k) clearances under its listings, the newest dated September 9, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3021246306
- Address
- Room 501, 502, 503 and 701-02 Building 22, No.388 Lianyun Road, Huangpu District, 510000 Guangzhou City, Guang, Guangzhou Guangdong, China, 510000
- Owner or operator
- Guangzhou Red Pine Medical Instrument Co., Ltd. (10083216)
- Roles
- Manufacturer
- First device listed
- November 3, 2021
- Registered through
- 2027
- Brand names listed
- Ascend Single-Use Flexible Cysto-Nephroscope HD, Ascend Single-Use Flexible Ureteroscope, Endoscopic Video Image Processor, Endoscopic Video Image Processor HD, Single-Use Biopsy Forceps, Single-Use Endoscopic Scissors, Single-Use Video Colonoscope, Single-Use Video Flexible Cysto-Nephroscope and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colonoscope And Accessories, Flexible/Rigid | FDF | 2 | Manufacturer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Manufacturer | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Manufacturer | accessdata.fda.gov |
| Gastroscope And Accessories, Flexible/Rigid | FDS | 2 | Manufacturer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Manufacturer | accessdata.fda.gov |
| Hysteroscope Accessories | NWW | 1 | Manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 9, 2026 | K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | FGB | Substantially Equivalent | Guangzhou Red Pine Medical Instrument Co., Ltd. | accessdata.fda.gov |
| December 16, 2025 | K251951 | 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) | FGB | Substantially Equivalent | Guangzhou Red Pine Medical Instrument Co., Ltd. | accessdata.fda.gov |
| August 8, 2025 | K252176 | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | FAJ | Substantially Equivalent | Guangzhou Red Pine Medical Instrument Co., Ltd. | accessdata.fda.gov |
| February 7, 2025 | K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F) | FET | Substantially Equivalent | Guangzhou Red Pine Medical Instrument Co., Ltd. | accessdata.fda.gov |
| August 2, 2024 | K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | HIH | Substantially Equivalent | Guangzhou Red Pine Medical Instrument Co., Ltd. | accessdata.fda.gov |
| July 12, 2024 | K241500 | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | FAJ | Substantially Equivalent | Guangzhou Red Pine Medical Instrument Co., Ltd. | accessdata.fda.gov |
| June 21, 2024 | K240663 | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) | FAJ | Substantially Equivalent | Guangzhou Red Pine Medical Instrument Co., Ltd. | accessdata.fda.gov |
| February 16, 2024 | K232043 | 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) | FDF | Substantially Equivalent | Guangzhou Red Pine Medical Instrument Co., Ltd. | accessdata.fda.gov |
| February 12, 2024 | K232003 | Endoscopic Video Image Processor, Single-Use Video Hysteroscope | HIH | Substantially Equivalent | Guangzhou Red Pine Medical Instrument Co., Ltd. | accessdata.fda.gov |
| March 6, 2023 | K221158 | Single-Use Video Flexible Ureterorenoscope System | FGB | Substantially Equivalent | Guangzhou Red Pine Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- All makers of Gastroscope And Accessories, Flexible/Rigid
- All makers of Colonoscope And Accessories, Flexible/Rigid
- All makers of Forceps, Biopsy, Non-Electric
- All makers of Hysteroscope (And Accessories)
Updated September 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.