Modification to Boston Scientific Express Biliary LD Premounted Stent System
FDA 510(k) K024048 · Boston Scientific Scimed, Inc.
510(k) numberK024048
Submission
- Device name
- Modification to Boston Scientific Express Biliary LD Premounted Stent System
- Applicant
- Boston Scientific Scimed, Inc.
Maple Grove, MN, US - Received
- December 9, 2002
- Decision date
- January 6, 2003
- Decision
- Unknown (SESU)
- Type
- Special 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 |
|---|---|---|
| K041727 | Modification to Atlantis PV Imaging Catheter, Model 36456OBJ · Special | 07/23/2004SE |
| K030617 | PT2 Guide Wire and Addwire Extension WireDQX · Abbreviated | 05/21/2003SE |
| K021735 | Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterDQY · Traditional | 08/08/2002SE |
| K021901 | Wallgraft Tracheobronchial Endoprothesis with Unistep Plus Delivery SystemJCT · Special | 07/09/2002SE |
| K012822 | Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model…FGE · Special | 10/24/2001SESU |
| K012216 | Niroyal Biliary Premounted Stent SystemFGE · Special | 08/17/2001SESU |
| K000743 | Boston Scientific Scimed Atlantis Coronary Imaging Catheter, Model C4020DQO · Traditional | 09/06/2000SE |
| K000001 | Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery SystemJCT · Traditional | 06/05/2000SE |
| K000956 | Modification to Scimed 6F Impulse Angiographic CathatersDQO · Special | 04/21/2000SE |
| K993232 | Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemFGE · Traditional | 12/30/1999SESU |
Questions and answers
When was Modification to Boston Scientific Express Biliary LD Premounted Stent System cleared by the FDA?
Modification to Boston Scientific Express Biliary LD Premounted Stent System (K024048) received a 510(k) decision of Unknown on January 6, 2003, 28 days after the submission was received.
What is the product code of K024048?
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.