Home / 510(k) Clearances / K241371

510(k) K241371

VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) by Olympus Medical Systems Corporation — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2024
Date Received
May 15, 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 Olympus Medical Systems Corporation

  • K250993 — Single Use Cytology Brush V (BC-V600P-3010) (December 18, 2025)
  • K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (November 25, 2025)
  • K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp (October 21, 2025)
  • K252247 — Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use (October 16, 2025)
  • K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical (October 10, 2025)
  • K250187 — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (October 7, 2025)
  • K252150 — Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); (October 7, 2025)
  • K251859 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (October 3, 2025)
  • K251986 — AUXILIARY WATER TUBE MAJ-855 (September 26, 2025)
  • K251997 — Single-Use Biopsy Valve (MAJ-1555) (September 25, 2025)

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)
  • K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F) (February 7, 2025)
  • K241532 — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (October 22, 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)