Home / 510(k) Clearances / K111788

510(k) K111788

ENDOEYE HD II by Olympus America, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2012
Date Received
June 24, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

Other clearances by Olympus America, Inc.

  • K081615 — OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN (March 18, 2009)
  • K073490 — OLYMPUS IGG REAGENT (February 11, 2008)
  • K073489 — OLYMPUS IGA REAGENT (February 11, 2008)
  • K073487 — OLYMPUS IGM REAGENT (February 11, 2008)
  • K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (April 6, 2007)
  • K063804 — OLYMPUS TRIGLYCERIDE TEST SYSTEM (March 23, 2007)
  • K061499 — OSFERION (January 26, 2007)
  • K062581 — OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM (November 29, 2006)
  • K061575 — OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 (October 5, 2006)
  • K060201 — OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028 (June 6, 2006)

Other clearances for product code HET

  • K250939 — SIRIUS Endoscope System (PR-SI-1230) (August 29, 2025)
  • K243821 — i-Cut (April 25, 2025)
  • K221642 — SIRIUS Endoscope System (December 12, 2022)
  • K210116 — Video Endoscopy System, 3D Video Endoscopy System (October 13, 2021)
  • K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 (September 17, 2021)
  • K210104 — SurroundScope System (July 8, 2021)
  • K201617 — TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera (March 12, 2021)
  • K200216 — 4K UHD Camera System (August 21, 2020)
  • K200638 — LAP-iX Suction Irrigation (April 3, 2020)
  • K190190 — WV1 Endoscope (November 1, 2019)