Home / 510(k) Clearances / K233275

510(k) K233275

RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) by Gyrus Acmi, Inc. — Product Code FGB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2024
Date Received
September 29, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

To perform various diagnostic and therapeutic 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).

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Other clearances for product code FGB

  • K260013 — CVAC Image Processor (March 6, 2026)
  • K252468 — Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible (December 16, 2025)
  • K251951 — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, (December 16, 2025)
  • K253411 — Miniature Telescope for Urology (27033AA) (November 18, 2025)
  • K250917 — Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: S (October 31, 2025)
  • K252806 — Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G- (October 3, 2025)
  • K252703 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure (September 24, 2025)
  • K250049 — Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscop (August 26, 2025)
  • K243550 — KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) (June 6, 2025)
  • K242699 — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Uretero (May 28, 2025)