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510(k) K252617

MiroCam® Capsule Endoscope System by Intromedic Co., Ltd. — Product Code NEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2026
Date Received
August 19, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Gastrointestinal, Wireless, Capsule
Device Class
Class II
Regulation Number
876.1300
Review Panel
GU
Submission Type

Other clearances by Intromedic Co., Ltd.

  • K180732 — MiroCam Capsule Endoscope System (November 8, 2018)
  • K170438 — MiroCam Capsule Endoscope System (January 30, 2018)
  • K143663 — MiroCam Capsule Endoscope System (March 17, 2015)
  • K134005 — MIROCAM CAPSULE ENDOSCOPE SYSTEM (July 9, 2014)
  • K140751 — MIROCAM CAPSULE ENDOSCOPE SYSTEM (June 30, 2014)
  • K131131 — E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM (June 21, 2013)
  • K123428 — MIROCAM CAPSULE ENDOSCOPE SYSTEM (May 20, 2013)
  • K120702 — E.G. SCAN II ESPHAGOSCOPE SYSTEM (June 20, 2012)
  • K111450 — MIROCAM CAPSULE ENDOSCOPE SYSTEM (May 18, 2012)
  • K111030 — E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM (October 21, 2011)

Other clearances for product code NEZ

  • K252480 — CE Deliver (DLV) (December 19, 2025)
  • K242643 — CapsoCam Plus (SV-3) Capsule Endoscopy System (December 4, 2024)
  • K240276 — PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader So (May 10, 2024)
  • K233229 — NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam (January 5, 2024)
  • K230991 — PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (June 30, 2023)
  • K221590 — NaviCam Small Bowel Capsule Endoscopy System (December 2, 2022)
  • K211684 — PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (August 27, 2021)
  • K192662 — CapsoCam Plus (SV-3) Capsule Endoscopy System (February 14, 2020)
  • K183192 — CapsoCam Plus (SV-3) (April 19, 2019)
  • K183053 — Olympus Small Intestinal Capsule Endoscope System (March 5, 2019)