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510(k) K233229

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether by Anx Robotica Corporation — Product Code NEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2024
Date Received
September 28, 2023
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 Anx Robotica Corporation

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Other clearances for product code NEZ

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  • 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)
  • 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)