Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
system, imaging, gastrointestinal, wireless, capsule
Regulation Description
Ingestible telemetric gastrointestinal capsule imaging system.
Product Code
NEZ
Regulation Number
876.1300
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANKON TECHNOLOGIES CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ANX ROBOTICA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
CAPSOVISION INC.
SUBSTANTIALLY EQUIVALENT
1
CAPSOVISION, INC.
SUBSTANTIALLY EQUIVALENT
1
GIVEN IMAGING LTD. (D.B.A. MEDTRONIC)
SUBSTANTIALLY EQUIVALENT
1
GIVEN IMAGING LTD. (MEDTRONIC)
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2020
31
31
2021
41
41
2022
63
63
2023
34
34
2024
102
102
2025
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
83
83
Entrapment of Device
78
78
Output Problem
24
24
Insufficient Information
18
18
Human-Device Interface Problem
10
10
Break
7
7
Detachment of Device or Device Component
7
7
Inadequacy of Device Shape and/or Size
5
5
Unintended Application Program Shut Down
5
5
Material Fragmentation
5
5
Difficult to Remove
4
4
Failure to Transmit Record
3
3
Therapeutic or Diagnostic Output Failure
3
3
No Apparent Adverse Event
3
3
Activation Problem
3
3
Data Problem
2
2
Positioning Problem
2
2
Patient-Device Incompatibility
2
2
Failure to Fire
2
2
Device Handling Problem
2
2
Material Protrusion/Extrusion
2
2
Patient Device Interaction Problem
2
2
Communication or Transmission Problem
2
2
Device Dislodged or Dislocated
1
1
Unexpected Therapeutic Results
1
1
Optical Distortion
1
1
Computer Operating System Problem
1
1
Activation, Positioning or Separation Problem
1
1
Image Display Error/Artifact
1
1
Activation Failure
1
1
Loss of Power
1
1
Defective Device
1
1
Improper or Incorrect Procedure or Method
1
1
Premature Discharge of Battery
1
1
Expulsion
1
1
Separation Problem
1
1
Failure to Clean Adequately
1
1
No Display/Image
1
1
Failure to Read Input Signal
1
1
Deflation Problem
1
1
Crack
1
1
Signal Artifact/Noise
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Foreign Body In Patient
140
140
No Clinical Signs, Symptoms or Conditions
62
62
Unintended Radiation Exposure
19
19
Insufficient Information
14
14
Abdominal Pain
14
14
Obstruction/Occlusion
12
12
Radiation Exposure, Unintended
8
8
No Known Impact Or Consequence To Patient
5
5
Discomfort
5
5
No Consequences Or Impact To Patient
5
5
Aspiration/Inhalation
4
4
Vomiting
4
4
Unspecified Gastrointestinal Problem
4
4
Pain
4
4
Nausea
3
3
Injury
3
3
Inflammation
3
3
No Information
3
3
Failure of Implant
2
2
Hypersensitivity/Allergic reaction
2
2
Tissue Breakdown
2
2
Death
2
2
Cough
2
2
Dyspnea
2
2
Burning Sensation
2
2
Foreign Body Reaction
2
2
Diarrhea
2
2
Low Oxygen Saturation
2
2
Weight Changes
2
2
Rash
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Undesired Nerve Stimulation
1
1
Syncope/Fainting
1
1
Perforation
1
1
Low Blood Pressure/ Hypotension
1
1
Laceration(s)
1
1
No Code Available
1
1
Ulcer
1
1
Bowel Perforation
1
1
Chest Pain
1
1
Unspecified Tissue Injury
1
1
Sepsis
1
1
Stenosis
1
1
Caustic/Chemical Burns
1
1
Laceration(s) of Esophagus
1
1
Airway Obstruction
1
1
Complaint, Ill-Defined
1
1
Anemia
1
1
Blister
1
1
Erythema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Capso Vision, Inc.
II
Jul-08-2020
2
Capso Vision, Inc.
II
May-21-2020
3
Capso Vision, Inc.
II
Apr-30-2020
-
-