Definition: To Examine Or Perform Procedures In The Colon Or Rectum 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 Ht
| Device Type ID | 1768 |
| Device Name | Colonoscope And Accessories, Flexible/rigid |
| Physical State | Endoscope, Accessories Associated With Colonoscope |
| Technical Method | Inserted Into Anus |
| Target Area | Colon Or Rectum |
| 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 | FDF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1768 |
| Device | Colonoscope And Accessories, Flexible/rigid |
| Product Code | FDF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AVANTIS MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FUJIFILM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
G I VIEW | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HOYA CORPORATION PENTAX DIVISION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INVENDO MEDICAL GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LUMENDI, LLC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDROBOTICS CORP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MOTUS GI MEDICAL TECHNOLOGIES LTD | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
PENTAX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Microbial Contamination Of Device | 806 |
No Display / Image | 168 |
Adverse Event Without Identified Device Or Use Problem | 104 |
Endoscope | 90 |
Device Reprocessing Problem | 55 |
Mechanical Problem | 30 |
Appropriate Term/Code Not Available | 21 |
Device Contamination With Chemical Or Other Material | 19 |
Insufficient Information | 15 |
Break | 13 |
Contamination / Decontamination Problem | 11 |
Material Deformation | 10 |
Material Too Rigid Or Stiff | 10 |
Obstruction Of Flow | 9 |
Device Operational Issue | 8 |
Device Issue | 8 |
Material Puncture / Hole | 7 |
Degraded | 6 |
Excess Flow Or Over-Infusion | 6 |
Material Protrusion / Extrusion | 6 |
Detachment Of Device Or Device Component | 6 |
Leak / Splash | 5 |
Poor Quality Image | 5 |
Burst Container Or Vessel | 5 |
Device Operates Differently Than Expected | 4 |
Use Of Device Problem | 4 |
Detachment Of Device Component | 4 |
Device Handling Problem | 4 |
Display Or Visual Feedback Problem | 4 |
Fluid Leak | 4 |
Material Perforation | 3 |
Material Separation | 3 |
Partial Blockage | 3 |
Electrical /Electronic Property Problem | 3 |
Material Integrity Problem | 3 |
Electro-Static Discharge | 2 |
Cap | 2 |
Difficult To Remove | 2 |
Occlusion Within Device | 2 |
Increase In Pressure | 2 |
Suction Problem | 2 |
Tip | 2 |
No Apparent Adverse Event | 2 |
Loss Of Or Failure To Bond | 2 |
Knob | 2 |
Pressure Problem | 2 |
Inadequate Or Insufficient Training | 2 |
Human Factors Issue | 2 |
Overheating Of Device | 2 |
Improper Flow Or Infusion | 2 |
Erratic Or Intermittent Display | 2 |
Entrapment Of Device | 1 |
Device Rinsing Issue | 1 |
Positioning Problem | 1 |
Scratched Material | 1 |
Disconnection | 1 |
Output Problem | 1 |
Temperature Problem | 1 |
Failure To Shut Off | 1 |
Difficult To Position | 1 |
Noise, Audible | 1 |
Failure To Power Up | 1 |
Complete Blockage | 1 |
EKG/ECG Analysis, Failure To Perform | 1 |
Patient Device Interaction Problem | 1 |
Intermittent Loss Of Power | 1 |
Mechanical Jam | 1 |
Physical Resistance / Sticking | 1 |
No Pressure | 1 |
Diode | 1 |
Peeled / Delaminated | 1 |
Inadequate Filtration Process | 1 |
Dent In Material | 1 |
Device Contamination With Biological Material | 1 |
Device-Device Incompatibility | 1 |
Gas Output Problem | 1 |
Deformation Due To Compressive Stress | 1 |
Delamination | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
No Flow | 1 |
Material Split, Cut Or Torn | 1 |
Residue After Decontamination | 1 |
Device Displays Incorrect Message | 1 |
Connection Problem | 1 |
Biofilm Coating In Device | 1 |
Sparking | 1 |
Patient-Device Incompatibility | 1 |
Communication Or Transmission Problem | 1 |
Fire | 1 |
Solder Joint Fracture | 1 |
Device Fell | 1 |
Valve | 1 |
Corroded | 1 |
Display Difficult To Read | 1 |
Image Resolution Poor | 1 |
Misconnection | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 1540 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EndoChoice, Inc. | II | Jan-27-2016 |
| 2 | Pentax Medical Company | II | Jul-23-2016 |
| 3 | Pentax Medical Company | II | Jun-28-2016 |
| 4 | Pentax Of America Inc | II | Nov-19-2016 |