CapsoCam (SV-1)
FDA 510(k) K151635 · CapsoVision, Inc.
510(k) numberK151635
Submission
- Device name
- CapsoCam (SV-1)
- Applicant
- CapsoVision, Inc.
Saratoga, CA, US - Received
- June 17, 2015
- Decision date
- February 9, 2016
- 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 |
| 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 |
More from CapsoVision, Inc.
| 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 |
| K192662 | CapsoCam Plus (SV-3) Capsule Endoscopy SystemNEZ · Traditional | 02/14/2020SE |
| K183192 | CapsoCam Plus (SV-3)NEZ · Special | 04/19/2019SE |
| K161773 | CapsoCam Plus (SV-3) Capsule Endoscope SystemNEZ · Traditional | 10/21/2016SE |
Questions and answers
When was CapsoCam (SV-1) cleared by the FDA?
CapsoCam (SV-1) (K151635) received a 510(k) decision of Substantially Equivalent on February 9, 2016, 237 days after the submission was received.
What is the product code of K151635?
The FDA product code is NEZ – System, Imaging, Gastrointestinal, Wireless, Capsule, a Class II (moderate risk) device regulated under 21 CFR 876.1300.