System, Imaging, Gastrointestinal, Wireless, Capsule

FDA product code NEZ · 41 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.1300
Review panel: GU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2002-05-02 – 2026-05-08

NEZ 2026-05-08

MiroCam® Capsule Endoscope System

Applicant Intromedic Co., Ltd.

K number K252617

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NEZ 2025-12-19

CE Deliver (DLV)

Applicant CapsoVision, Inc.

K number K252480

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NEZ 2024-12-04

CapsoCam Plus (SV-3) Capsule Endoscopy System

Applicant CapsoVision, Inc.

K number K242643

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NEZ 2024-05-10

PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software

Applicant Given Imaging Ltd. (D.B.A. Medtronic)

K number K240276

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NEZ 2024-01-05

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether

Applicant Anx Robotica Corporation

K number K233229

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NEZ 2023-06-30

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

Applicant Given Imaging Ltd. (Medtronic)

K number K230991

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NEZ 2022-12-02

NaviCam Small Bowel Capsule Endoscopy System

Applicant Ankon Technologies Co., Ltd.

K number K221590

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NEZ 2021-08-27

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

Applicant Given Imaging Ltd. (Medtronic)

K number K211684

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NEZ 2020-02-14

CapsoCam Plus (SV-3) Capsule Endoscopy System

Applicant CapsoVision, Inc.

K number K192662

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NEZ 2019-04-19

CapsoCam Plus (SV-3)

Applicant CapsoVision, Inc.

K number K183192

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NEZ 2019-03-05

Olympus Small Intestinal Capsule Endoscope System

Applicant Olympus Medical Systems Corp.

K number K183053

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NEZ 2018-11-08

MiroCam Capsule Endoscope System

Applicant Intromedic Co., Ltd.

K number K180732

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NEZ 2018-03-13

Olympus Small Intestinal Capsule Endoscope System

Applicant Olympus Medical Systems Corp.

K number K173459

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NEZ 2018-01-30

MiroCam Capsule Endoscope System

Applicant Intromedic Co., Ltd.

K number K170438

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NEZ 2017-09-01

PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0

Applicant Given Imaging , Ltd.

K number K170210

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NEZ 2017-05-26

RAPID Web

Applicant Given Imaging , Ltd.

K number K170839

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NEZ 2017-03-10

AdvanCE capsule endoscope delivery device

Applicant United States Endoscopy Group, Inc.

K number K163495

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NEZ 2017-01-19

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

Applicant Olympus Medical Systems Corp.

K number K163069

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NEZ 2016-10-21

CapsoCam Plus (SV-3) Capsule Endoscope System

Applicant CapsoVision, Inc.

K number K161773

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NEZ 2016-02-09

CapsoCam (SV-1)

Applicant CapsoVision, Inc.

K number K151635

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NEZ 2013-08-12

GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM

Applicant Given Imaging , Ltd.

K number K123864

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NEZ 2013-05-20

MIROCAM CAPSULE ENDOSCOPE SYSTEM

Applicant Intromedic Co., Ltd.

K number K123428

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NEZ 2013-04-29

OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

Applicant Olympus Medical Systems Corp.

K number K123421

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NEZ 2012-05-18

MIROCAM CAPSULE ENDOSCOPE SYSTEM

Applicant Intromedic Co., Ltd.

K number K111450

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NEZ 2011-05-13

GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES

Applicant Given Imaging , Ltd.

K number K103025

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NEZ 2011-03-07

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES

Applicant Given Imaging , Ltd.

K number K101250

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NEZ 2011-01-14

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT

Applicant Given Imaging , Ltd.

K number K103088

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NEZ 2010-09-30

PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE

Applicant Given Imaging , Ltd.

K number K101200

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NEZ 2009-07-29

PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT

Applicant Given Imaging , Ltd.

K number K091405

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NEZ 2009-07-29

MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM

Applicant Olympus Medical Systems Corporation

K number K090210

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NEZ 2007-09-14

OLYMPUS CAPSULE ENDOSCOPE SYSTEM

Applicant Olympus Medical Systems Corporation

K number K063259

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NEZ 2007-05-07

MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM

Applicant Given Imaging , Ltd.

K number K070475

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NEZ 2006-10-18

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

Applicant Given Imaging , Ltd.

K number K062786

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NEZ 2006-05-08

GIVEN DIAGNOSTIC SYSTEM

Applicant Given Imaging , Ltd.

K number K053639

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NEZ 2004-06-23

CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144

Applicant United States Endoscopy Group, Inc.

K number K040494

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NEZ 2004-02-17

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

Applicant Given Imaging , Ltd.

K number K040248

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NEZ 2003-10-29

GIVEN DIAGNOSTIC SYSTEM

Applicant Given Imaging , Ltd.

K number K032405

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NEZ 2003-07-01

GIVEN DIAGNOSTIC SYSTEM

Applicant Given Imaging , Ltd.

K number K031033

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NEZ 2003-02-27

MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

Applicant Given Imaging , Ltd.

K number K022980

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NEZ 2002-08-09

GIVEN DIAGNOSTICS SYSTEM

Applicant Given Imaging , Ltd.

K number K022362

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NEZ 2002-05-02

GIVEN DIAGNOSTIC SYSTEM

Applicant Given Imaging , Ltd.

K number K020341

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