MiroCam Capsule Endoscope System
FDA 510(k) K170438 · Intromedic Co., Ltd.
510(k) numberK170438
Submission
- Device name
- MiroCam Capsule Endoscope System
- Applicant
- Intromedic Co., Ltd.
Seoul, KR - Received
- February 13, 2017
- Decision date
- January 30, 2018
- 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 |
|---|---|---|
| K252617 | MiroCam® Capsule Endoscope SystemNEZ · Special | 05/08/2026SE |
| K180732 | MiroCam Capsule Endoscope SystemNEZ · Traditional | 11/08/2018SE |
| K143663 | MiroCam Capsule Endoscope SystemNEZ · Traditional | 03/17/2015SE |
| K134005 | Mirocam Capsule Endoscope SystemNEZ · Traditional | 07/09/2014SE |
| K140751 | Mirocam Capsule Endoscope SystemNEZ · Traditional | 06/30/2014SE |
| K131131 | E.G. Scan(Tm) II Esophagoscope SystemEOX · Special | 06/21/2013SE |
| K123428 | Mirocam Capsule Endoscope SystemNEZ · Traditional | 05/20/2013SE |
| K120702 | E.G. Scan II Esphagoscope SystemEOX · Traditional | 06/20/2012SE |
| K111450 | Mirocam Capsule Endoscope SystemNEZ · Traditional | 05/18/2012SE |
| K111030 | E.G. Scan (TM) Esophagoscope SystemEOX · Traditional | 10/21/2011SE |
Questions and answers
When was MiroCam Capsule Endoscope System cleared by the FDA?
MiroCam Capsule Endoscope System (K170438) received a 510(k) decision of Substantially Equivalent on January 30, 2018, 351 days after the submission was received.
What is the product code of K170438?
The FDA product code is NEZ – System, Imaging, Gastrointestinal, Wireless, Capsule, a Class II (moderate risk) device regulated under 21 CFR 876.1300.