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510(k) K243321

Endoscopic Video Image Processor (RP-IPD-V1000F) by Guangzhou Red Pine Medical Instrument Co., Ltd. — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2025
Date Received
October 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

Other clearances by Guangzhou Red Pine Medical Instrument Co., Ltd.

  • K251951 — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, (December 16, 2025)
  • K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (August 8, 2025)
  • K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (August 2, 2024)
  • K241500 — Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cys (July 12, 2024)
  • K240663 — Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) (June 21, 2024)
  • K232043 — Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, (February 16, 2024)
  • K232003 — Endoscopic Video Image Processor, Single-Use Video Hysteroscope (February 12, 2024)
  • K221158 — Single-Use Video Flexible Ureterorenoscope System (March 6, 2023)

Other clearances for product code FET

  • K251734 — ProVee Video Processing Unit (PV-003) (September 24, 2025)
  • K250462 — UL UHD-Clear View 4K Camera System (UL-3Chip 4K) (August 11, 2025)
  • K250204 — Endoscopic Camera System (July 1, 2025)
  • K243260 — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (April 11, 2025)
  • K242067 — VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGH (April 2, 2025)
  • K241532 — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (October 22, 2024)
  • K241371 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (July 3, 2024)
  • K222584 — EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100D (April 26, 2023)
  • K212808 — Logic Hd camera head green, System green (June 14, 2022)
  • K221174 — Telepack + (May 13, 2022)