Definition: To Facilitate Enteral Specific Connections.
| Device Type ID | 2098 |
| Device Name | Gastrointestinal Tubes With Enteral Specific Connectors |
| Physical State | Plastic Connector |
| Technical Method | The Connector Is Attached To An Enteral Tube And Is Intended To Facilitate The Administration Of Hydration, Medication, And Feed To A Patient. |
| Target Area | The Gastrointestinal Tract |
| Regulation Description | Gastrointestinal Tube 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) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5980 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PIF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2098 |
| Device | Gastrointestinal Tubes With Enteral Specific Connectors |
| Product Code | PIF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| CFR Regulation Number | 876.5980 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APPLIED MEDICAL TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS | 2 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS | 2 | |
CARDINAL HEALTH 200, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONOD MEDICAL CO., LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORPAK MEDSYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
DEGANIA SILICONE, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAQUET CRITICAL CARE AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAQUET, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MOOG, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NESTLE HEALTHCARE NUTRITION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XERIDIEM (FORMERLY MRI) | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
XERIDIEM MEDICAL DEVICES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZEVEX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Tube | 18 |
Device Operates Differently Than Expected | 15 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Fracture | 8 |
Occlusion Within Device | 6 |
Difficult To Advance | 6 |
Migration Or Expulsion Of Device | 5 |
Entrapment Of Device | 4 |
Torn Material | 3 |
Detachment Of Device Component | 3 |
Human-Device Interface Problem | 3 |
Device Appears To Trigger Rejection | 1 |
Material Integrity Problem | 1 |
Balloon | 1 |
Poor Quality Image | 1 |
Device Handling Problem | 1 |
Probe | 1 |
Crack | 1 |
Fluid Leak | 1 |
| Total Device Problems | 88 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | MOOG Medical Devices Group | II | Dec-14-2015 |
| 2 | Xeridiem Mediem Medical Devices Inc | II | Feb-26-2016 |