Definition: To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submissi
| Device Type ID | 2074 |
| Device Name | Endoscopic Ultrasound System, Gastroenterology-urology |
| Physical State | Ultrasound System And System Accessories, Endoscope |
| Technical Method | Uses Ultrasound To Visualize Body Cavities 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 | ODG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2074 |
| Device | Endoscopic Ultrasound System, Gastroenterology-urology |
| Product Code | ODG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FUJIFILM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOYA CORPORATION PENTAX DIVISION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Microbial Contamination Of Device | 126 |
Endoscope | 31 |
Adverse Event Without Identified Device Or Use Problem | 23 |
Contamination / Decontamination Problem | 21 |
Needle | 8 |
Device Reprocessing Problem | 5 |
Temperature Problem | 4 |
Overheating Of Device | 4 |
Detachment Of Device Or Device Component | 3 |
Device Contamination With Chemical Or Other Material | 3 |
Material Separation | 2 |
Device Packaging Compromised | 2 |
Material Perforation | 2 |
Insufficient Information | 2 |
Material Puncture / Hole | 2 |
Seal | 2 |
Smoking | 1 |
Obstruction Of Flow | 1 |
Activation, Positioning Or Separation Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Migration Or Expulsion Of Device | 1 |
Sparking | 1 |
Material Discolored | 1 |
Difficult To Position | 1 |
Break | 1 |
Mechanical Problem | 1 |
Excess Flow Or Over-Infusion | 1 |
Device Damaged By Another Device | 1 |
Detachment Of Device Component | 1 |
Leak / Splash | 1 |
| Total Device Problems | 254 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Micro-Tech (Nanjing) Co., Ltd. | II | May-15-2018 |
| 2 | Olympus Corporation Of The Americas | II | Sep-28-2015 |
| 3 | Pentax Medical Company | II | Jul-23-2016 |
| 4 | Pentax Of America Inc | II | Aug-23-2017 |