Product code PJH
- Device name
- Dynamic Rectal Control System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5930
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Intended to treat fecal incontinence by controlling the size of the rectal lumen.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K150558 | Eclipse System | Pelvalon, Inc. | 2015-11-12 |
| DEN140020 | ECLIPSE SYSTEM | Pelvalon | 2015-02-12 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00815430020159 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020296 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020289 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020272 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020265 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020258 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020241 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020234 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020227 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020210 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020203 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020197 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020180 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020173 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020166 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020005 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020142 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020135 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020128 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020111 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020104 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020098 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020081 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020074 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020067 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020050 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020043 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020036 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020029 | Eclipse | PELVALON, INC. | 2016-09-23 |
| 00815430020012 | Eclipse | PELVALON, INC. | 2016-09-23 |