510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Guangzhou Red Pine Medical Instrument Co.,Ltd.

Guangzhou Guangdong, CN

GUANGZHOU RED PINE MEDICAL INSTRUMENT CO.,LTD. appears in FDA device records in Guangzhou Guangdong, CN. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for Guangzhou Red Pine Medical Instrument Co.,Ltd. between 2023 and 2025. The busiest year on record is 2024, with 5. The most recent is 2025, with 3.

Clearances by year, as a table
510(k) clearance decisions for Guangzhou Red Pine Medical Instrument Co.,Ltd., by decision year
YearClearances
20231
20245
20253
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
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)FGBSubstantially Equivalent
K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)FAJSubstantially Equivalent
K243321Endoscopic Video Image Processor (RP-IPD-V1000F)FETSubstantially Equivalent
K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)HIHSubstantially Equivalent
K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)FAJSubstantially Equivalent
K240663Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)FAJSubstantially Equivalent
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)FDFSubstantially Equivalent
K232003Endoscopic Video Image Processor, Single-Use Video HysteroscopeHIHSubstantially Equivalent
K221158Single-Use Video Flexible Ureterorenoscope SystemFGBSubstantially Equivalent

Registered establishments

FDA registered establishments for Guangzhou Red Pine Medical Instrument Co.,Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30212463063021246306GUANGZHOU RED PINE MEDICAL INSTRUMENT CO.,LTD.Room 501, 502, 503 and 701-02 Building 22, No.388 Lianyun Road, Huangpu District, 510000 Guangzhou City, Guang, Guangzhou Guangdong 510000 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain