Intrastent Doublestrut Paramount XS Biliary Endoprosthesis
FDA 510(k) K011184 · Intratherapeutics, Inc.
510(k) numberK011184
Submission
- Device name
- Intrastent Doublestrut Paramount XS Biliary Endoprosthesis
- Applicant
- Intratherapeutics, Inc.
Saint Paul, MN, US - Received
- April 18, 2001
- Decision date
- August 13, 2001
- 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 |
|---|---|---|
| K003997 | Intrastent Doublestrut Paramount XS Biliary EndoprosthesisFGE · Special | 01/24/2001SESU |
| K003040 | Intrastent Protege Self-Expanding Nitinol Stent with Starport Delivery TechnologyFGE · Traditional | 12/28/2000SESU |
| K003450 | Intrastent Doublestrut Paramount Biliary EndoprosthesisFGE · Special | 12/07/2000SESU |
| K001648 | Intrastent Doublestrut ParamountFGE · Traditional | 08/28/2000SE |
| K001257 | Intracoil StentJCT · Special | 05/18/2000SE |
| K000864 | Intrastent Doublestrut XS StentFGE · Special | 04/14/2000SE |
| K993904 | Intrastent Doublestrut LDFGE · Traditional | 02/01/2000SESU |
| K992816 | Modification to IntrastentFGE · Special | 10/15/1999SESU |
| K992622 | Intramax Iti Guide CatheterDQY · Special | 09/29/1999SE |
| K990592 | Intrastent IIFGE · Traditional | 09/01/1999SESU |
Questions and answers
When was Intrastent Doublestrut Paramount XS Biliary Endoprosthesis cleared by the FDA?
Intrastent Doublestrut Paramount XS Biliary Endoprosthesis (K011184) received a 510(k) decision of Unknown on August 13, 2001, 117 days after the submission was received.
What is the product code of K011184?
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.