Renew Inserts
Renew Inserts help manage accidental bowel leakage caused by bowel incontinence. The user places a soft silicone insert in the anal canal using a removable fingertip applicator. An upper…
Renew Inserts help manage accidental bowel leakage caused by bowel incontinence. The user places a soft silicone insert in the anal canal using a removable fingertip applicator. An upper disk rests against the lower rectum to help form a seal against involuntary stool leakage.
An elastic stem spans the anal canal, and an outer disk helps hold the insert in position. Regular and large sizes accommodate different anatomies. The insert can be expelled during a voluntary bowel movement or removed manually by the user.
Listed Item
Starter Pack of 5 individually packaged Renew Inserts consisting of 3 regular size and 2 large size single shot Inserts
Individual Supply
Each insert is supplied preassembled with its applicator in a nonsterile, single-use blister pack. Users start with the regular size and move to the large size if the insert is inadvertently lost or leakage occurs around it.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
Record
| Listed by | Renew Group Private Limited, Singapore |
|---|---|
| FDA product code | PBP |
| Device type | Rectal Insert |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K122003 |
| Record published | 2017-10-01 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 16, case of 48 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FG715 | In distribution | ||
| FG731 | 30 | In distribution | |
| 702 | In distribution | ||
| 706 | 30 | In distribution | |
| 707 | 30 | In distribution | |
| FG730 | 30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| StaySure | Minnesota Medical Technologies | 6 |
| Navina Inserts | Renew Group Private Limited | 3 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122003 | 2012-10-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.