PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
FDA 510(k) K240276 · Given Imaging Ltd. (D.B.A. Medtronic)
510(k) numberK240276
Submission
- Device name
- PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
- Applicant
- Given Imaging Ltd. (D.B.A. Medtronic)
Yoqneam Northern, IL - Received
- January 31, 2024
- Decision date
- May 10, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEZ – System, Imaging, Gastrointestinal, Wireless, Capsule
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1300
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code NEZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252617 | MiroCam® Capsule Endoscope SystemNEZ · Special | Intromedic Co., Ltd. | 05/08/2026SE |
| K252480 | CE Deliver (DLV)NEZ · Traditional | CapsoVision, Inc. | 12/19/2025SE |
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy SystemNEZ · Traditional | CapsoVision, Inc. | 12/04/2024SE |
| K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherNEZ · Traditional | Anx Robotica Corporation | 01/05/2024SE |
| K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0ENEZ · Special | Given Imaging Ltd. (Medtronic) | 06/30/2023SE |
| K221590 | NaviCam Small Bowel Capsule Endoscopy SystemNEZ · Traditional | Ankon Technologies Co., Ltd. | 12/02/2022SE |
| K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0ENEZ · Traditional | Given Imaging Ltd. (Medtronic) | 08/27/2021SE |
| K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy SystemNEZ · Traditional | CapsoVision, Inc. | 02/14/2020SE |
| K183192 | CapsoCam Plus (SV-3)NEZ · Special | CapsoVision, Inc. | 04/19/2019SE |
| K183053 | Olympus Small Intestinal Capsule Endoscope SystemNEZ · Traditional | Olympus Medical Systems Corp. | 03/05/2019SE |
Questions and answers
When was PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software cleared by the FDA?
PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software (K240276) received a 510(k) decision of Substantially Equivalent on May 10, 2024, 100 days after the submission was received.
What is the product code of K240276?
The FDA product code is NEZ – System, Imaging, Gastrointestinal, Wireless, Capsule, a Class II (moderate risk) device regulated under 21 CFR 876.1300.