| Device Type ID | 1675 |
| Device Name | Collector, Ostomy |
| Regulation Description | Ostomy Pouch 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 | 876.5900 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EXB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1675 |
| Device | Collector, Ostomy |
| Product Code | EXB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ostomy Pouch And Accessories. |
| CFR Regulation Number | 876.5900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
11 HEALTH AND TECHNOLOGIES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 16 |
Human-Device Interface Problem | 10 |
Malposition Of Device | 9 |
Biocompatibility | 4 |
Insufficient Information | 2 |
Leak / Splash | 2 |
Material Deformation | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Occlusion Within Device | 1 |
No Flow | 1 |
| Total Device Problems | 47 |