Niti-S Biliary Speed D Stent
FDA 510(k) K223626 · Taewoong Medical Co., Ltd.
510(k) numberK223626
Submission
- Device name
- Niti-S Biliary Speed D Stent
- Applicant
- Taewoong Medical Co., Ltd.
Gimpo-Si, KR - Received
- December 5, 2022
- Decision date
- May 26, 2023
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code FGE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260835 | ARCHIMEDES Biodegradable Stent (Medium)FGE · Traditional | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 07/27/2026SE |
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018…FGE · Traditional | Hangzhou AGS MedTech Co., Ltd. | 06/24/2026SE |
| K253832 | Dilation Balloon CatheterFGE · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 04/24/2026SE |
| K251658 | Endoflux Biliary & Pancreatic Stent SetsFGE · Traditional | Medi-Globe GmbH | 04/16/2026SE |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235)FGE · Traditional | GIE Medical | 03/13/2026SE |
| K253132 | Single use stone retrieval balloonsFGE · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 03/06/2026SE |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE · Traditional | Taewoong Medical Co., Ltd. | 12/29/2025SESU |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional | Bioteque Corporation | 12/22/2025SE |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…FGE · Traditional | Olympus Medical Systems Corporation | 10/21/2025SE |
| K251229 | EndoFixTissue Fixation SystemFGE · Traditional | Softac Medical Technologies | 08/20/2025SE |
More from Softac Medical Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K260962 | SphincterotomeKNS · Traditional | 05/21/2026SE |
| K252648 | Niti-S SPAXUS StentPCU · Traditional | 03/13/2026SE |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE · Traditional | 12/29/2025SESU |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS StentESW · Traditional | 10/30/2025SE |
| K250663 | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentMUM · Special | 03/31/2025SE |
| K240522 | Esophageal TTS StentESW · Special | 03/22/2024SE |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort StentMUM · Traditional | 06/14/2023SE |
| K223256 | Optimos CystotomeKNS · Traditional | 04/05/2023SE |
| K221482 | Esophageal TTS StentESW · Special | 06/22/2022SE |
| K221071 | Niti-S Biliary Slim M StentFGE · Traditional | 06/09/2022SESU |
Questions and answers
When was Niti-S Biliary Speed D Stent cleared by the FDA?
Niti-S Biliary Speed D Stent (K223626) received a 510(k) decision of Unknown on May 26, 2023, 172 days after the submission was received.
What is the product code of K223626?
The FDA product code is FGE – Stents, Drains And Dilators For The Biliary Ducts, a Class II (moderate risk) device regulated under 21 CFR 876.5010.