K232043
- 510(k) number
- K232043
- Device name
- 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)
- Applicant
- Guangzhou Red Pine Medical Instrument Co., Ltd. CN
- Product code
- FDF — Colonoscope And Accessories, Flexible/Rigid
- Decision date
- 2024-02-16
- Date received
- 2023-07-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K232043.pdf
Official FDA record: K232043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.