Definition: To Examine And Perform Procedures Within The Bile Ducts. 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 H
| Device Type ID | 1737 |
| Device Name | Choledochoscope And Accessories, Flexible/rigid |
| Physical State | Endoscope, Accessories Associated With Choledochoscope |
| Technical Method | Instrument Guided Laparoscopically Or Through The Esophagus Into The Biliary Tree |
| Target Area | Bile Ducts |
| 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 | FBN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1737 |
| Device | Choledochoscope And Accessories, Flexible/rigid |
| Product Code | FBN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ENDOCURE TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Protrusion / Extrusion | 1038 |
Optical Problem | 33 |
Detachment Of Device Component | 15 |
Difficult To Advance | 12 |
Poor Quality Image | 11 |
Microbial Contamination Of Device | 10 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Tip | 8 |
Device-Device Incompatibility | 8 |
Break | 4 |
Endoscope | 4 |
Appropriate Term/Code Not Available | 3 |
Detachment Of Device Or Device Component | 3 |
Defective Device | 2 |
Material Separation | 2 |
Contamination / Decontamination Problem | 2 |
Material Integrity Problem | 2 |
Difficult To Remove | 2 |
Device Reprocessing Problem | 1 |
Fracture | 1 |
Contamination During Use | 1 |
Connection Problem | 1 |
Electrical /Electronic Property Problem | 1 |
No Display / Image | 1 |
Retraction Problem | 1 |
Seal | 1 |
Device Packaging Compromised | 1 |
Material Deformation | 1 |
Peeled / Delaminated | 1 |
Device Contamination With Biological Material | 1 |
Leak / Splash | 1 |
Material Perforation | 1 |
Torn Material | 1 |
Positioning Problem | 1 |
Entrapment Of Device | 1 |
Device Disinfection Or Sterilization Issue | 1 |
| Total Device Problems | 1186 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Boston Scientific Corporation | II | Mar-19-2018 |
| 2 | Olympus Corporation Of The Americas | II | Feb-24-2017 |
| 3 | Pentax Medical Company | II | Jun-28-2016 |