Definition: To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
| Device Type ID | 1782 |
| Device Name | Endoscopic Access Overtube, Gastroenterology-urology |
| Physical State | Overtube |
| Technical Method | Endoscope Inserted And Advanced Through Center Of Device |
| Target Area | Various Openings In Gi And Gu Tract |
| 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 | FED |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1782 |
| Device | Endoscopic Access Overtube, Gastroenterology-urology |
| Product Code | FED |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BODDINGTONS PLASTICS LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C2 THERAPEUTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLOPLAST MANUFACTURING US LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ENDO-AID, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIVATORS REPROCESSING SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIVATORS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRO-TECH (NAN JING) CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VISIONSENSE LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WELL LEAD MEDICAL CO. LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Shaft | 25 |
Adverse Event Without Identified Device Or Use Problem | 12 |
Torn Material | 12 |
Appropriate Term/Code Not Available | 10 |
Break | 9 |
Peeled / Delaminated | 9 |
Fracture | 5 |
Device Contamination With Chemical Or Other Material | 4 |
Detachment Of Device Component | 4 |
Insufficient Information | 4 |
Material Perforation | 3 |
Partial Blockage | 3 |
Tip | 3 |
Delamination | 2 |
Patient-Device Incompatibility | 2 |
Flaked | 2 |
Difficult To Advance | 1 |
Microbial Contamination Of Device | 1 |
Detachment Of Device Or Device Component | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Material Separation | 1 |
Device Packaging Compromised | 1 |
Device Handling Problem | 1 |
Inflation Problem | 1 |
Difficult To Remove | 1 |
Wrinkled | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Failure To Advance | 1 |
Material Integrity Problem | 1 |
Deflation Problem | 1 |
Retraction Problem | 1 |
Structural Problem | 1 |
| Total Device Problems | 125 |