Definition: Intended To Support, Secure, And Hold Gastrostomy Tubes
| Device Type ID | 2105 |
| Device Name | Gastrostomy Tube Holder |
| Physical State | Cloth Material Held Together By Fasteners |
| Technical Method | Holds Gastrostomy Tube In Place Using Strap |
| Target Area | Abdomen |
| 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) Exempt |
| CFR Regulation Number | 876.5980 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2105 |
| Device | Gastrostomy Tube Holder |
| Product Code | PLI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| CFR Regulation Number | 876.5980 [🔎] |