CapsoCam Plus (SV-3) Capsule Endoscopy System
FDA 510(k) K192662 · CapsoVision, Inc.
510(k) numberK192662
Submission
- Device name
- CapsoCam Plus (SV-3) Capsule Endoscopy System
- Applicant
- CapsoVision, Inc.
Saratoga, CA, US - Received
- September 25, 2019
- Decision date
- February 14, 2020
- 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 |
| K240276 | PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareNEZ · Traditional | Given Imaging Ltd. (D.B.A. Medtronic) | 05/10/2024SE |
| 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 |
| 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 |
More from Olympus Medical Systems Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K252480 | CE Deliver (DLV)NEZ · Traditional | 12/19/2025SE |
| K242643 | CapsoCam Plus (SV-3) Capsule Endoscopy SystemNEZ · Traditional | 12/04/2024SE |
| K183192 | CapsoCam Plus (SV-3)NEZ · Special | 04/19/2019SE |
| K161773 | CapsoCam Plus (SV-3) Capsule Endoscope SystemNEZ · Traditional | 10/21/2016SE |
| K151635 | CapsoCam (SV-1)NEZ · Traditional | 02/09/2016SE |
Questions and answers
When was CapsoCam Plus (SV-3) Capsule Endoscopy System cleared by the FDA?
CapsoCam Plus (SV-3) Capsule Endoscopy System (K192662) received a 510(k) decision of Substantially Equivalent on February 14, 2020, 142 days after the submission was received.
What is the product code of K192662?
The FDA product code is NEZ – System, Imaging, Gastrointestinal, Wireless, Capsule, a Class II (moderate risk) device regulated under 21 CFR 876.1300.