Home / 510(k) Clearances / K211882

510(k) K211882

HD-550 Video Endoscope System by Sonoscape Medical Corp. — Product Code NWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2022
Date Received
June 21, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Accessories, Narrow Band Spectrum
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.

Other clearances by Sonoscape Medical Corp.

  • K252498 — Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 (December 5, 2025)
  • K241949 — Digital Color Doppler Ultrasound System (P60 Series) (January 17, 2025)
  • K231813 — Ultrasonic Gastrovideoscope (March 8, 2024)
  • K222596 — S90 Exp Series Digital Color Doppler Ultrasound System (February 10, 2023)
  • K221089 — P12 Elite Series Digital Color Doppler Ultrasound System (September 15, 2022)
  • K221140 — P20 Elite Series Digital Color Doppler Ultrasound System (September 13, 2022)
  • K222020 — HD-550 Video Endoscope System (September 8, 2022)
  • K201059 — S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (July 30, 2020)
  • K182648 — X5 Series Digital Color Doppler Ultrasound System (January 29, 2019)
  • K173921 — HD-500 Video Endoscope System (September 5, 2018)

Other clearances for product code NWB

  • K222020 — HD-550 Video Endoscope System (September 8, 2022)
  • K173921 — HD-500 Video Endoscope System (September 5, 2018)
  • K133538 — VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCO (August 7, 2014)
  • K100584 — EVIS EXERAII 180 SYSTEM (July 2, 2010)
  • K090980 — HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L (June 29, 2009)
  • K072957 — EVIS EXERA II 180 SYSTEM (March 18, 2008)
  • K062049 — EVIS EXERA II 180 SYSTEM (September 22, 2006)
  • K051645 — EVIS EXERA 160A SYSTEM (October 13, 2005)