The following data is part of a premarket notification filed by Taewoong Medical Co., Ltd with the FDA for Niti-s Biliary Slim M Stent.
| Device ID | K221071 |
| 510k Number | K221071 |
| Device Name: | Niti-S Biliary Slim M Stent |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Taewoong Medical Co., Ltd 14 Gojeong-ro, Wolgot-myeon Gimpo-si, KR 10022 |
| Contact | Jangsoo Lee |
| Correspondent | Matthew Krueger Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | SE - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-12 |
| Decision Date | 2022-06-09 |