Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
FDA 510(k) clearance K250663 · decided 2025-03-31
Clearance details
- K-number
- K250663
- Device name
- Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
- Applicant
- Taewoong Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-05
- Decision date
- 2025-03-31
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- MUM
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Gyeonggi-Do, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (K223067) | Taewoong Medical Co., Ltd. | 2023-06-14 |
| Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered (K163468) | Cook Ireland, Ltd. | 2017-05-04 |
| EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D (K101530) | Cook Ireland, Ltd. | 2011-03-29 |
| WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 (K062750) | Boston Scientific Corp | 2006-12-04 |
| WALLSTENT ENTERAL ENDOPROSTHESIS (K980113) | Boston Scientific Scimed, Inc. | 1998-04-03 |
Recalls involving this device
No recalls on record reference this clearance.