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510(k) K240276

PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software by Given Imaging Ltd. (D.B.A. Medtronic) — Product Code NEZ

K240276 is an FDA 510(k) premarket notification submitted by Given Imaging Ltd. (D.B.A. Medtronic) for the device "PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software". The FDA issued a decision of Substantially Equivalent on May 10, 2024. The device falls under product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule), a Class II device regulated under 21 CFR 876.1300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2024
Date Received
January 31, 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 for product code NEZ

  • K252617 — MiroCam® Capsule Endoscope System (May 8, 2026)
  • K252480 — CE Deliver (DLV) (December 19, 2025)
  • K242643 — CapsoCam Plus (SV-3) Capsule Endoscopy System (December 4, 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)

FDA data resources