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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809744975399 | K221071 | 000 |
| 08809744975252 | K221071 | 000 |
| 08809744975269 | K221071 | 000 |
| 08809744975276 | K221071 | 000 |
| 08809744975283 | K221071 | 000 |
| 08809744975290 | K221071 | 000 |
| 08809744975306 | K221071 | 000 |
| 08809744975313 | K221071 | 000 |
| 08809744975320 | K221071 | 000 |
| 08809744975337 | K221071 | 000 |
| 08809744975344 | K221071 | 000 |
| 08809744975351 | K221071 | 000 |
| 08809744975368 | K221071 | 000 |
| 08809744975375 | K221071 | 000 |
| 08809744975382 | K221071 | 000 |
| 08809744975245 | K221071 | 000 |