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510(k) K210579

WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System by OTU Medical, Inc. — Product Code FGB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2021
Date Received
February 26, 2021
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).

Other clearances by OTU Medical, Inc.

  • K231702 — WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystosc (September 29, 2023)
  • K220399 — WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Broncho (June 16, 2022)
  • K212202 — WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscop (April 13, 2022)
  • K181977 — WiScope Digital Endoscope System (August 14, 2018)

Other clearances for product code FGB

  • K252929 — Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (M (April 9, 2026)
  • 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)