BEUDAMED
    Product Code: NEZ FDA class 2 21 CFR 876.1300

    System, Imaging, Gastrointestinal, Wireless, Capsule

    Gastroenterology, Urology

    The System, Imaging, Gastrointestinal, Wireless, Capsule (product code NEZ) is a swallowable wireless capsule endoscopy system that captures images or video of the gastrointestinal tract as it passes through, enabling visualization of areas difficult to reach with conventional endoscopy. It is classified as an FDA Class 2 device within the Gastroenterology and Urology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as a permanent implant or life-sustaining device.

    View on FDA
    510(k)s
    47
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    10
    Years Active
    25

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    Basic Information

    Product Code
    NEZ
    Device Class
    FDA class 2
    Regulation Number
    876.1300
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 47 510(k) clearances via K numbers.

    K Number Device Name
    K252617 MiroCam® Capsule Endoscope System
    K252480 CE Deliver (DLV)
    K242643 CapsoCam Plus (SV-3) Capsule Endoscopy System
    K240276 PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
    K233229 NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
    K230991 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
    K221590 NaviCam Small Bowel Capsule Endoscopy System
    K211684 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
    K192662 CapsoCam Plus (SV-3) Capsule Endoscopy System
    K183192 CapsoCam Plus (SV-3)
    K183053 Olympus Small Intestinal Capsule Endoscope System
    K180732 MiroCam Capsule Endoscope System
    K173459 Olympus Small Intestinal Capsule Endoscope System
    K170438 MiroCam Capsule Endoscope System
    K170210 PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
    K170839 RAPID Web
    K163495 AdvanCE capsule endoscope delivery device
    K163069 OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
    K161773 CapsoCam Plus (SV-3) Capsule Endoscope System
    K151635 CapsoCam (SV-1)
    K143663 MiroCam Capsule Endoscope System
    K142680 ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT
    K140284 GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
    K134005 MIROCAM CAPSULE ENDOSCOPE SYSTEM
    K140751 MIROCAM CAPSULE ENDOSCOPE SYSTEM
    K123864 GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
    K123428 MIROCAM CAPSULE ENDOSCOPE SYSTEM
    K123421 OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
    K111450 MIROCAM CAPSULE ENDOSCOPE SYSTEM
    K103025 GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
    K101250 GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
    K103088 GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
    K101200 PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
    K091405 PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
    K090210 MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
    K063259 OLYMPUS CAPSULE ENDOSCOPE SYSTEM
    K070475 MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
    K062786 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
    K053639 GIVEN DIAGNOSTIC SYSTEM
    K040494 CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144
    K040248 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
    K032405 GIVEN DIAGNOSTIC SYSTEM
    K031033 GIVEN DIAGNOSTIC SYSTEM
    K022980 MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
    K022362 GIVEN DIAGNOSTICS SYSTEM
    K020341 GIVEN DIAGNOSTIC SYSTEM
    DEN010002 GIVEN DIAGNOSTIC IMAGING SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.