| Device Type ID | 5610 |
| Device Name | Catheter, Pediatric, General & Plastic Surgery |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GBN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5610 |
| Device | Catheter, Pediatric, General & Plastic Surgery |
| Product Code | GBN |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| CFR Regulation Number | 878.4200 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Customed, Inc | I | Dec-16-2014 |