FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
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)
K Number: K251951
·
Decision Dec 16, 2025
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
112
Applicant Total
9
Review Days
174
Basic Information
- Device Name
- 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)
- K Number
- K251951
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guangzhou Red Pine Medical Instrument Co., Ltd.
- Date Received
- June 25, 2025
- Decision Date
- December 16, 2025
- Product Code
- FGB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Guangzhou Red Pine Medical Instrument Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252176 | Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Aug 8, 2025 | Substantially Equivalent |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F) | Feb 7, 2025 | Substantially Equivalent |
| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | Aug 2, 2024 | Substantially Equivalent |
| K241500 | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Jul 12, 2024 | Substantially Equivalent |
| K240663 | Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) | Jun 21, 2024 | Substantially Equivalent |
| 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) | Feb 16, 2024 | Substantially Equivalent |
| K232003 | Endoscopic Video Image Processor, Single-Use Video Hysteroscope | Feb 12, 2024 | Substantially Equivalent |
| K221158 | Single-Use Video Flexible Ureterorenoscope System | Mar 6, 2023 | Substantially Equivalent |