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510(k) K242643

CapsoCam Plus (SV-3) Capsule Endoscopy System by CapsoVision, Inc. — Product Code NEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2024
Date Received
September 3, 2024
Clearance Type
Traditional
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 CapsoVision, Inc.

  • K252480 — CE Deliver (DLV) (December 19, 2025)
  • K192662 — CapsoCam Plus (SV-3) Capsule Endoscopy System (February 14, 2020)
  • K183192 — CapsoCam Plus (SV-3) (April 19, 2019)
  • K161773 — CapsoCam Plus (SV-3) Capsule Endoscope System (October 21, 2016)
  • K151635 — CapsoCam (SV-1) (February 9, 2016)

Other clearances for product code NEZ

  • K252480 — CE Deliver (DLV) (December 19, 2025)
  • 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)
  • K180732 — MiroCam Capsule Endoscope System (November 8, 2018)