Rectal Insert
The Rectal Insert is a gastrointestinal and urology device that acts as a physical barrier to the passage of fecal matter through the rectum, intended for patients with fecal incontinence or related conditions. It falls under the Gastroenterology and Urology medical specialty and is classified as a Class 2 device under regulation 876.5980, requiring 510(k) premarket notification. The device is eligible for third-party review and is subject to general controls and special controls. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- PBP
- Device Class
- FDA class 2
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Acts as a barrier to the passage of fecal matter through the rectum.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K122003 | RENEW INSERT | Oct 26, 2012 | Substantially Equivalent | RENEW MEDICAL, INC. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.