NEZ · Class II · 21 CFR 876.1300

FDA Product Code NEZ: System, Imaging, Gastrointestinal, Wireless, Capsule

Leading manufacturers include CapsoVision, Inc., Olympus Medical Systems Corp. and Intromedic Co., Ltd..

47
Total
46
Cleared
149d
Avg days
2001
Since
Declining activity - 3 submissions in the last 2 years vs 4 in the prior period
Consistent review times: 163d avg (recent)

FDA 510(k) Cleared System, Imaging, Gastrointestinal, Wireless, Capsule Devices (Product Code NEZ)

47 devices
1–24 of 47
Cleared May 08, 2026
MiroCam® Capsule Endoscope System
K252617
Intromedic Co., Ltd.
Gastroenterology & Urology · 262d
Cleared Dec 19, 2025
CE Deliver (DLV)
K252480
CapsoVision, Inc.
Gastroenterology & Urology · 134d
Cleared Dec 04, 2024
CapsoCam Plus (SV-3) Capsule Endoscopy System
K242643
CapsoVision, Inc.
Gastroenterology & Urology · 92d
Cleared May 10, 2024
PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
K240276
Given Imaging Ltd. (D.B.A. Medtronic)
Gastroenterology & Urology · 100d
Cleared Jan 05, 2024
NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
K233229
Anx Robotica Corporation
Gastroenterology & Urology · 99d
Cleared Jun 30, 2023
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
K230991
Given Imaging Ltd. (Medtronic)
Gastroenterology & Urology · 85d
Cleared Dec 02, 2022
NaviCam Small Bowel Capsule Endoscopy System
K221590
Ankon Technologies Co., Ltd.
Gastroenterology & Urology · 183d
Cleared Aug 27, 2021
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
K211684
Given Imaging Ltd. (Medtronic)
Gastroenterology & Urology · 87d
Cleared Feb 14, 2020
CapsoCam Plus (SV-3) Capsule Endoscopy System
K192662
CapsoVision, Inc.
Gastroenterology & Urology · 142d
Cleared Apr 19, 2019
CapsoCam Plus (SV-3)
K183192
CapsoVision, Inc.
Gastroenterology & Urology · 151d
Cleared Mar 05, 2019
Olympus Small Intestinal Capsule Endoscope System
K183053
Olympus Medical Systems Corp.
Gastroenterology & Urology · 123d
Cleared Nov 08, 2018
MiroCam Capsule Endoscope System
K180732
Intromedic Co., Ltd.
Gastroenterology & Urology · 233d
Cleared Mar 13, 2018
Olympus Small Intestinal Capsule Endoscope System
K173459
Olympus Medical Systems Corp.
Gastroenterology & Urology · 126d
Cleared Jan 30, 2018
MiroCam Capsule Endoscope System
K170438
Intromedic Co., Ltd.
Gastroenterology & Urology · 351d
Cleared Mar 10, 2017
AdvanCE capsule endoscope delivery device
K163495
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 87d
Cleared Jan 19, 2017
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K163069
Olympus Medical Systems Corp.
Gastroenterology & Urology · 78d

About Product Code NEZ - Regulatory Context

510(k) Submission Activity

47 total 510(k) submissions under product code NEZ since 2001, with 46 receiving FDA clearance (average review time: 149 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - NEZ Product Code

FDA review times for NEZ submissions have been consistent, averaging 163 days recently vs 148 days historically.

NEZ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →