Definition: To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 FR 26807, Available At Https://w
| Device Type ID | 1774 |
| Device Name | Gastroscope And Accessories, Flexible/rigid |
| Physical State | Endoscope, Accessories Associated With Gastroscope |
| Technical Method | Inserted Orally Into The Stomach |
| Target Area | Stomach |
| 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 | FDS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1774 |
| Device | Gastroscope And Accessories, Flexible/rigid |
| Product Code | FDS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ENDOCHOICE INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJI | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FUJIFILM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GI SCIENTIFIC LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOYA CORPORATION PENTAX DIVISION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PENTAX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Microbial Contamination Of Device | 411 |
Device Reprocessing Problem | 57 |
Endoscope | 57 |
Adverse Event Without Identified Device Or Use Problem | 34 |
No Display / Image | 23 |
Obstruction Of Flow | 12 |
Appropriate Term/Code Not Available | 11 |
Insufficient Information | 11 |
Device Contamination With Chemical Or Other Material | 11 |
Contamination / Decontamination Problem | 10 |
Image Display Error / Artifact | 7 |
Failure To Align | 7 |
Break | 7 |
Fluid Leak | 7 |
Detachment Of Device Or Device Component | 6 |
Sticking | 6 |
Degraded | 6 |
Connection Problem | 5 |
Misconnection | 5 |
Device Issue | 5 |
Mechanical Jam | 5 |
Device Handling Problem | 4 |
Leak / Splash | 4 |
Overheating Of Device | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Difficult To Insert | 3 |
Partial Blockage | 3 |
Material Deformation | 3 |
Detachment Of Device Component | 2 |
Device Contamination With Biological Material | 2 |
Material Fragmentation | 2 |
Scratched Material | 2 |
Material Integrity Problem | 2 |
Difficult To Remove | 2 |
Tip | 2 |
Use Of Device Problem | 2 |
Signal Artifact | 1 |
Loss Of Or Failure To Bond | 1 |
Difficult To Open Or Close | 1 |
Device Dislodged Or Dislocated | 1 |
Electrical /Electronic Property Problem | 1 |
Increase In Pressure | 1 |
Infusion Or Flow Problem | 1 |
Fire | 1 |
Cap | 1 |
Device Fell | 1 |
Product Quality Problem | 1 |
Material Discolored | 1 |
Image Resolution Poor | 1 |
Disconnection | 1 |
Kinked | 1 |
Difficult To Position | 1 |
Cut In Material | 1 |
Mechanical Problem | 1 |
Display Or Visual Feedback Problem | 1 |
Temperature Problem | 1 |
Torn Material | 1 |
Needle | 1 |
Material Separation | 1 |
Component Or Accessory Incompatibility | 1 |
Material Protrusion / Extrusion | 1 |
Complete Blockage | 1 |
Device-Device Incompatibility | 1 |
Cover | 1 |
Monitor | 1 |
| Total Device Problems | 773 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Fujifilm Medical Systems U.S.A., Inc. | II | Jul-10-2017 |
| 2 | Pentax Medical Company | II | Jun-28-2016 |
| 3 | Pentax Medical Company | II | Jul-24-2014 |
| 4 | Pentax Of America Inc | II | Oct-26-2016 |