Home / 510(k) Clearances / K252176

510(k) K252176

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) by Guangzhou Red Pine Medical Instrument Co., Ltd. — Product Code FAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2025
Date Received
July 11, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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)
  • K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F) (February 7, 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 FAJ

  • K253226 — UV5000W Handle (October 23, 2025)
  • K251140 — Zenflow Spring Scope (September 23, 2025)
  • K252598 — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (September 15, 2025)
  • K250797 — UV5000 Handle (September 11, 2025)
  • K243653 — KARL STORZ HOPKINS Telescopes for Urology (August 13, 2025)
  • K251652 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS- (August 1, 2025)
  • K250269 — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Revers (June 11, 2025)
  • K242535 — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G (December 18, 2024)
  • K243196 — Uro-G HD Cystoscope (1520) (December 13, 2024)
  • K240849 — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Revers (October 16, 2024)