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510(k) K100584

EVIS EXERAII 180 SYSTEM by Olympus Medical Systems Corporation — Product Code NWB

K100584 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "EVIS EXERAII 180 SYSTEM". The FDA issued a decision of Substantially Equivalent on July 2, 2010. The device falls under product code NWB (Endoscope, Accessories, Narrow Band Spectrum), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2010
Date Received
March 2, 2010
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 Olympus Medical Systems Corporation

  • K261260 — HD Camera Head OLYMPUS CH-S200-08-LB (June 24, 2026)
  • K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D (March 20, 2026)
  • 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)

Other clearances for product code NWB

  • K222020 — HD-550 Video Endoscope System (September 8, 2022)
  • K211882 — HD-550 Video Endoscope System (April 1, 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)
  • 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)

FDA data resources