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)— 510(k) K232043
Substantially EquivalentGuangzhou Red Pine Medical Instrument Co., Ltd.
FDA 510(k) clearance K232043 for 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), Substantially Equivalent on 2024-02-16. Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Red Pine Medical Instrument Co., Ltd.
- Product code
- Code FDF
- 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
Recent devices under product code FDF
view allMore 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 FDF
product code FDF- Death
- 8
- Injury
- 729
- Malfunction
- 61,773
- Total
- 62,510
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.