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510(k) K201617

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) by Schoelly Fiberoptic GmbH — Product Code HET

K201617 is an FDA 510(k) premarket notification submitted by Schoelly Fiberoptic GmbH for the device "TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))". The FDA issued a decision of Substantially Equivalent on March 12, 2021. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Schoelly Fiberoptic GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2021
Date Received
June 15, 2020
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 Schoelly Fiberoptic GmbH

  • K233225 — SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Cam (June 20, 2024)
  • K221591 — Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic sc (February 23, 2023)
  • K201970 — Schoelly Cystoscopes/Hysteroscopes and Accessories (October 8, 2020)
  • K151308 — Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (February 9, 2016)
  • K150158 — Schoelly Cystoscopes/Hysteroscopes and Accessories (March 9, 2015)
  • K143673 — CMOS Video Nasopharyngoscope System (March 4, 2015)
  • K142249 — SCHOELLY SINUSCOPE (January 27, 2015)
  • K143221 — Schoelly Laparoscope (December 5, 2014)
  • K132009 — CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM (April 9, 2014)
  • K992362 — FLEXISCOPE IQ 101 (August 5, 1999)

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)
  • K200216 — 4K UHD Camera System (August 21, 2020)
  • K200638 — LAP-iX Suction Irrigation (April 3, 2020)
  • K190190 — WV1 Endoscope (November 1, 2019)
  • K190744 — ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) (August 29, 2019)

FDA data resources