| Device Type ID | 1761 |
| Device Name | Insufflator, Automatic Carbon-dioxide For Endoscope |
| 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 | FCX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1761 |
| Device | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Product Code | FCX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BRACCO DIAGNOSTIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJI | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJIFILM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 13 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Insufficient Information | 7 |
Improper Flow Or Infusion | 3 |
No Flow | 2 |
Infusion Or Flow Problem | 2 |
Device Operational Issue | 1 |
Inaccurate Flow Rate | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Use Of Device Problem | 1 |
Circuit Failure | 1 |
Electrical /Electronic Property Problem | 1 |
Increase In Pressure | 1 |
Break | 1 |
Malposition Of Device | 1 |
Unintended Movement | 1 |
| Total Device Problems | 48 |