Definition: Acts As A Barrier To The Passage Of Fecal Matter Through The Rectum.
| Device Type ID | 2084 |
| Device Name | Rectal Insert |
| Physical State | Comprised Of A Silicone Insert And A Plastic Fingertip Applicator. The Insert Has A Barbell Shape, The End Which Sits Inside Of The Rectum Ranges In Size From 22 Mm To 28 Mm In Width. The Insert Is 35 Mm Long And The External Flare Is 24 Mm. |
| Technical Method | Designed For Self-insertion To Seal And Prevent The Involuntary Leakage Of Stool From The Rectum. |
| Target Area | To Be Placed Across The Anal Sphincter. |
| 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 | PBP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2084 |
| Device | Rectal Insert |
| Product Code | PBP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Tube And Accessories. |
| CFR Regulation Number | 876.5980 [🔎] |