Home / 510(k) Clearances / K211684

510(k) K211684

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E by Given Imaging Ltd. (Medtronic) — Product Code NEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2021
Date Received
June 1, 2021
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 Given Imaging Ltd. (Medtronic)

  • K230991 — PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (June 30, 2023)

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)
  • 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)