Home / 510(k) Clearances / K253696

510(k) K253696

CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) by Verathon Medical (Canada) Ulc — Product Code FAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2026
Date Received
November 21, 2025
Clearance Type
Traditional
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 Verathon Medical (Canada) Ulc

  • K230948 — BFlex™ 2 Slim 3.8 Single-Use Bronchoscope (May 3, 2023)
  • K211947 — GlideScope BFlex 2.8 Single-Use Bronchoscope (November 3, 2021)
  • K193488 — GlideScope BFlex 3.8 Single-Use Bronchoscope (January 16, 2020)
  • K191948 — GlideScope BFlex 5.8 Single-Use Bronchoscope (August 21, 2019)
  • K183256 — GlideScope BFlex Single-Use Bronchoscope System (January 4, 2019)

Other clearances for product code FAJ

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  • K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x (April 16, 2026)
  • K253905 — PrimeSight UltraView System (April 7, 2026)
  • K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments (March 27, 2026)
  • 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)
  • K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (August 8, 2025)