Home / 510(k) Clearances / K102949

510(k) K102949

COLONOSCOPY ASSISTANT by Sti Medical Systems, LLC — Product Code FET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2011
Date Received
October 5, 2010
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 Sti Medical Systems, LLC

  • K110147 — ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE (April 8, 2011)
  • K090324 — ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY (December 20, 2010)
  • K072691 — CERVICAL MD, MODEL C10 (January 31, 2008)

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)
  • K241371 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (July 3, 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)