The following data is part of a premarket notification filed by Ureteral Stent Company with the FDA for Relief Ureteral Stent Kit; Model: Rs-001 - 6 Fr X 24cm, Relief Ureteral Stent Kit; Model: Rs-002 - 6 Fr X 26cm.
| Device ID | K213444 |
| 510k Number | K213444 |
| Device Name: | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr X 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr X 26cm |
| Classification | Stent, Ureteral |
| Applicant | Ureteral Stent Company 45 Glenridge Court Chagrin Falls, OH 44022 |
| Contact | Mike Bunker |
| Correspondent | Mike Bunker Ureteral Stent Company 45 Glenridge Court Chagrin Falls, OH 44022 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-25 |
| Decision Date | 2022-03-17 |