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510(k) K100345

SYSTEMS INTEGRATION MODEL: ENDOALPHA by Olympus Medical Systems Corporation — Product Code ODA

K100345 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "SYSTEMS INTEGRATION MODEL: ENDOALPHA". The FDA issued a decision of Substantially Equivalent on March 22, 2010. The device falls under product code ODA (Endoscopic Central Control Unit), 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
March 22, 2010
Date Received
February 5, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Central Control Unit
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.

Other clearances by Olympus Medical Systems Corporation

  • K260401 — EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F) (August 27, 2026)
  • K260824 — Gastrointestinal Videoscope Olympus GIF-2T1500 (August 27, 2026)
  • K260856 — Disposable Distal Attachment D-201-13404 (August 27, 2026)
  • K261183 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (July 31, 2026)
  • 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)

Other clearances for product code ODA

  • K232406 — KARL STORZ OR1™ SCB CONTROL (WU300) (October 3, 2023)
  • K221929 — Smith+Nephew INTELLIO Tablet (September 6, 2022)
  • K203566 — Tablet Application (May 13, 2021)
  • K192876 — INTELLIO Tablet Application (February 27, 2020)
  • K153205 — IDSS ForceTriad Control Module (August 1, 2016)
  • K151282 — core nova Complete Operating Room Endoscopy (January 12, 2016)
  • K111165 — KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE (January 6, 2012)
  • K102763 — SYSTEMS INTEGRATION (February 15, 2011)
  • K083598 — KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION (May 29, 2009)
  • K080410 — KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 (April 9, 2008)

FDA data resources