Definition: To Provide Visualization And Perform Various Procedures Within The Small Intestine. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (
| Device Type ID | 1764 |
| Device Name | Enteroscope And Accessories |
| Physical State | Enteroscope And Related Accessories, May Include Balloon, Mini-scope |
| Technical Method | Inserted Through Mouth Or Laparoscopically |
| Target Area | Small Intestine |
| 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 | FDA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1764 |
| Device | Enteroscope And Accessories |
| Product Code | FDA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FUJIFILM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 34 |
Adverse Event Without Identified Device Or Use Problem | 7 |
Insufficient Information | 5 |
Microbial Contamination Of Device | 4 |
Use Of Device Problem | 4 |
Misconnection | 3 |
Inflation Problem | 3 |
Device Operates Differently Than Expected | 2 |
Device Reprocessing Problem | 2 |
Endoscope | 2 |
Endoscopic Accessory | 2 |
Mechanical Problem | 2 |
Display Or Visual Feedback Problem | 1 |
Detachment Of Device Component | 1 |
Device Contamination With Chemical Or Other Material | 1 |
No Apparent Adverse Event | 1 |
Balloon | 1 |
Connection Problem | 1 |
| Total Device Problems | 76 |