StaySure
Fecal Incontinence Insert, StaySure, 10-Pack, Standard
1manufacturer
6catalogue numbers in this listing
1510(k) clearance
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 | Minnesota Medical Technologies, United States |
|---|---|
| FDA product code | PBP |
| Device type | Rectal Insert |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Manufacturer |
| 510(k) | K243367 |
| Record published | 2026-03-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 110105 | Large | 30 | In distribution |
| 110103 | Standard | 30 | In distribution |
| 110106 | Large | 30 | In distribution |
| 110115 | In distribution | ||
| 110104 | Standard | 30 | In distribution |
| 110114 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Renew Inserts | Renew Group Private Limited | 6 |
| Navina Inserts | Renew Group Private Limited | 3 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243367 | 2025-07-22 |
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.