Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)— 510(k) K240663
Substantially EquivalentGuangzhou Red Pine Medical Instrument Co., Ltd.
FDA 510(k) clearance K240663 for Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S), Substantially Equivalent on 2024-06-21. Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Red Pine Medical Instrument Co., Ltd.
- Product code
- Code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
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More clearances from Guangzhou Red Pine Medical Instrument Co., Ltd.
view all- K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
- K251951 — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3) +2 more
- K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
- K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F)
- K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
Adverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.