Definition: To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
| Device Type ID | 1794 |
| Device Name | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Physical State | May Include: Ccd Camera, Monitor, Other Software Or Hardware Associated With Video Equiptment, And Components From Other Regulations, Such As A Pump. |
| Technical Method | Inserted Through Endoscope. |
| Target Area | Various Body Cavities, Hollow Organs, And Canals In Gi And Gu Tract. |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FET |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1794 |
| Device | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Product Code | FET |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FUJI | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KARL STORZ GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RICHARD WOLF | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
W.O.M. WORLD OF MEDICINE AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO, LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Microbial Contamination Of Device | 36 |
No Display / Image | 14 |
Device Inoperable | 13 |
Electrical /Electronic Property Problem | 10 |
Erratic Or Intermittent Display | 9 |
Device Operates Differently Than Expected | 8 |
Mechanical Problem | 6 |
Poor Quality Image | 5 |
Reflux Within Device | 5 |
Appropriate Term/Code Not Available | 5 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Display Or Visual Feedback Problem | 4 |
Failure To Power Up | 3 |
Endoscope | 3 |
Signal Artifact | 3 |
Residue After Decontamination | 2 |
Connection Problem | 2 |
Programming Issue | 2 |
Unintended Electrical Shock | 2 |
Image Display Error / Artifact | 2 |
Computer Software Problem | 2 |
Thermal Decomposition Of Device | 1 |
Grounding Malfunction | 1 |
Moisture Damage | 1 |
No Device Output | 1 |
Overheating Of Device | 1 |
Defective Device | 1 |
Insufficient Information | 1 |
Noise, Audible | 1 |
Accessory Incompatible | 1 |
Material Deformation | 1 |
Optical Problem | 1 |
Material Too Rigid Or Stiff | 1 |
Unexpected Shutdown | 1 |
Excess Flow Or Over-Infusion | 1 |
Infusion Or Flow Problem | 1 |
Communication Or Transmission Problem | 1 |
Power Problem | 1 |
Inappropriate Shock | 1 |
Electrical Power Problem | 1 |
Device Displays Incorrect Message | 1 |
Optical Distortion | 1 |
Device Dislodged Or Dislocated | 1 |
Failure To Auto Stop | 1 |
| Total Device Problems | 163 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Fujifilm Medical Systems U.S.A., Inc. | II | Sep-22-2015 |
| 2 | Karl Storz Endoscopy | II | Jul-06-2016 |
| 3 | Olympus Corporation Of The Americas | II | Jun-21-2018 |